Careers

Description for Textile Engineer:

This position will implement product design and process development activities with compliance to all quality and regulatory requirements. This is a full-time, on-site position. This role is an Independent Contributor role. There are no direct reports for this position. Interaction is potentially with all levels of the organization.

Responsibilities for Textile Engineer:

• Interface with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.
• Project member for new design and development teams of medical fibers and textiles.
• Provide technical expertise to improve process efficiency/product quality.
• Support new equipment/process implementation.
• Conduct process validation activities.
• Provide cost-saving initiatives by evaluating manufacturing processes while maintaining quality standards.
• Create and analyze prototype products.
• Design experiments to provide data based conclusion about a process or product performance.
• Design products, equipment or fixtures using CAD techniques.
• Recommend and rationalize specifications for development products.
• Develop test methods for evaluation of new products.
• Implementation of process improvements and monitoring for efficacy.
• Assist with implementing corrective actions (CAPA) with QA.
• Procure new testing and manufacturing equipment using IQ/OQ/PQ process validation techniques.
• Operate processing equipment in a specific process area.
• Conduct analytical techniques with the ability to interpret results for project recommendations.
• Lead and provide input to risk assessment activities such as FMEA.
• Assist in creation of publishable research findings in the form of abstracts, papers and grants.
• Support patent filing and claims.
• Write technical reports detailing procedures, outcomes, and observations.

Required/Preferable Knowledge, Skills and Abilities for Textile Engineer:

• Must have experience with textile processing such as fiber extrusion, fiber winding, fiber warping, knitting (warp) and heat treatment of fiber and textiles.
• Prior experience with medical fibers and textiles preferred, especially bioabsorbable/bioresorbable materials.
• Prior experience working in an ISO 9001, ISO 13485, or GMP facility.
• Ability to handle confidential business information.
• Understanding of statistical methods and associated statistical analysis software. Preferred experience with Minitab
• Understanding of cause-effect relations between process inputs and product specifications.
• Understanding of the effect of a process on downstream steps or customer needs.
• Ability to design experiments and evaluate data using polymer and textile characterization techniques (tensile, burst, tear, porosity, DSC, GPC, viscosity, etc.).
• Ability to be a team player.
• Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.

Education/Experience Requirements for Textile Engineer:

Required-Bachelor’s Degree with 1 or more years’ industry experience

Preferred-Advanced Degree (M.S. or Ph.D.) with 1-2 years’ industry experience

Physical Requirements for Textile Engineer:

Requires walking, ability to climb stairs, stoop, kneel, and reach above shoulder heights and below waist throughout the day. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required.

Working Conditions for Textile Engineer:

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med Employees are eligible for multiple benefits including vacation, choice in health benefits and optional plans. Poly-Med, Inc. is on a once a month payday schedule.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

The Quality Engineer position is responsible for performing Quality Engineering tasks and activities with some guidance and supervision. Has knowledge of commonly used concepts, practices, and procedures within quality assurance field. Relies on personal engineering experience and judgment to perform primary job responsibilities supporting design and development teams. This role is an Independent Contributor with no direct reports. Interaction is potentially with all levels of the organization. Progression path would be to a senior level Quality Engineer based on performance, development, and experience. This position reports to a more senior Quality Engineer, Assistant Manager or Quality Manager.

Responsibilities for Quality Engineer:

• Participates in design and development project meetings as the Quality representative supporting regulatory compliance and PMI Quality position in product design and development documentation.
• Supports compliance to Good Documentation Practices during assigned document reviews.
• Responsible for document management related to assigned product such as batch cards, MIs, DHR, DMR, DMF,CAPA, ECO, Validations, IP/PS, customer complaints, FMEA, Customer Proposals, Drawings, Design Control, SDS’, Calibrations, NCR, Product shipping and Label Control.
• Participates in customer and regulatory audits as well as internal audits as required. When trained may be internal or external auditor. For this some travel may be required.
• Responsible for the ISO 13485 and cGMP compliance of the assigned projects and programs.
• Meet annual Quality Objectives as set with manager as well as assigned Quality metrics.
• Recommends and implements Quality process improvements with the approval of Quality Manager.
• Perform validations or participate in validation teams or work on analytical equipment validation as required by project.

Required Knowledge, Skills and Abilities for Quality Engineer:

• Fluency with Microsoft Office Software (Microsoft Word, Excel, et. al.)
• Excellent technical writing skills, grammar, proof reading skills
• Excellent organizational skills, attention to detail, ability to manage time and prioritize
• Ability to think proactively, troubleshoot, investigate and improve systems
• Excellent communication and interpersonal skills, able to assertively interact with people at all levels of the organization
• Ability to lead projects and train others as required
• Ability to handle confidential business information

Education/Experience Requirements for Quality Engineer:

• Required – Bachelor’s Degree in chemical, plastics or polymer engineering.
• Preferred – At least 1 year experience in medical device, pharmaceutical or similarly cGMP/ISO regulated industry

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Description:

Create a detailed business analysis with focus on ERP and software systems, outlining problem areas, opportunities and solutions. Defining business requirements and presenting them back to stakeholders.

Responsibilities:

• Own the business processes value stream with focus on ERP Systems & supporting tools to promote efficient strategic decision making for PMI leadership.
• Assist PMI leadership with developing the right KPI’s and monitoring them towards success (Includes areas of Budgeting, Forecasting, Planning, and Monitoring through designed reports)
• Through Value Stream Analysis (define As-Is, define road-map for future, and own the continuous improvement of business systems)
• As the BA Project Manager, create Project Estimates and Manage Continuous Improvements in the BA domain
• Define system requirements, working with PMI IT team as needed
• Lead development, test, and implementation of solutions
• Properly document the BA environment & improvements
• Be comfortable in leading multi-discipline team meetings and training PMI all staff
• Champion effective technical reports through gathering, analyzing and summarizing data and trends
• Maintain current knowledge of latest business process and relative IT innovations.
• Ensure confidential nature of PMI business information

Review a variety of PMI operational areas including business development, R&D, manufacturing, AR/AP, inventory, and facilities.

Required/Preferable Knowledge, Skills and Abilities:

• Minimum 3-5 years implementing ERP (SAP, Oracle, EIQ preferred)
• A history of leading and managing successful BA projects
• Process mapping, test validations, scripts, and reporting
• Software analysis, design, release, maintenance
• Detail oriented, analytical and inquisitive
• Ability to work independently and with others
• Organized with strong time-management skills
• Experience creating detailed reports and giving presentations
• Microsoft Access and/or SQL experience strongly preferred
• Competency in Microsoft applications including Word, Excel, and Outlook
• IT and Consulting background preferred

Education/Experience Requirements:

Required- Bachelor’s Degree in appropriate field of study or equivalent work experience (5yrs experience preferred)

Working Conditions at Poly-Med, Inc.:

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Description:

The Planner will lead production planning activities in close cooperation with manufacturing, sales, purchasing and other functions. Based on information and sales/management input, the Planner develops weekly, monthly, and/or quarterly production plans to achieve revenue and inventory targets.

Responsibilities:

• Plan, coordinate, and communicate production schedules.
• Plan production orders to meet customer ship dates.
• Meet with production personnel to communicate production plan.
• Plan Engineering runs to support development and validation work.
• Schedule equipment and coordinate resources with appropriate manager or designee to produce products while minimizing waste and improving efficiency.
• Collaborate with Procurement to ensure purchase and receipt of raw materials and packaging materials needed to deliver quality product on time.
• Communicate with Business Development regarding acceptance of orders and requested ship dates.
• Coordinate with Maintenance on Preventative Maintenance (PM) work that needs to be completed on production and production support equipment.
• Manage (create, plan, adjust) work orders based on Production and Engineering needs.
• Coordinate Work Order status with Quality (i.e. printing, releasing, lot approvals).
• Coordinate with Inventory and Shipping for on time shipments.
• Perform additional duties as assigned by management.

Required/Preferable Knowledge, Skills and Abilities

• Strong detail oriented and the ability to follow documented procedures
• Experience in a manufacturing environment and able to understand the process flows.
• Ability to operate and be effective with a minimum of direct supervision
• Ability to work effectively with time pressures and multiple changing priorities
• Ability to communicate effectively with all levels of the organization
• Team player
• Dependable
• Strong math skills and computer skills, primarily MS Excel and Word
• Experience in an ERP system is preferable.
• Experience with MS Project is preferable.
• Must be able to utilize/view a PC and/or monitor

 

Education/Experience Requirements:

Required: High School Diploma or Equivalent and 2 years of related professional experience in Planning; Material Requirements Planning (MRP) a plus     

Preferred: Bachelor’s Degree or equivalent planning experience preferred.

 

Environmental/Physical Requirements:

Must be able to adapt to multiple indoor work environments (shared office space, shared lab space and production areas).  Must be able to walk, bend, stoop, crawl, push, and reach for extended periods of time.

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

 

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

This position is self-directed and is responsible for performing HR tasks and activities under general supervision and guidance. Relies on personal experience and judgment to perform primary job responsibilities.

Scope for Human Resources Specialist – Hiring and Recruiting:

This role is an Independent Contributor role; there are no direct reports for this position. Interaction is potentially with all levels of the organization. This position reports to the Corporate Manager.

Responsibilities for Human Resources Specialist:

1. Maintains compliance with federal and state regulations concerning employment with focus on specialty (i.e. training, benefits or recruiting).
2. Administers human resource information system (electronic) records and compiles reports from the database.
3. Coordinates system in employee’s specialty (i.e. training specialist coordinates the training process, hiring specialist coordinates the hiring and recruiting process).
4. Communicates with other groups and departments of Poly-Med, Inc. clearly and effectively in regards to the employee’s specialty.
5. Responsible to report status of projects/tasks in employee’s specialty.
6. Plan and execute tasks/projects in a timely manner.
7. Keeps employee records up to date by processing employee status changes in timely fashion.
8. Prepares paper files required to place employees in system and maintains information in that system (with focus on specialty – i.e. training system or benefits system or recruiting system).
9. Processes personnel action forms and ensures proper approvals; disseminates approved forms.
10. Additional responsibilities may be assigned by management.

Specific Responsibilities for Human Resources Specialist – Hiring and Recruiting:

1. Provide full cycle recruiting/hiring services including job posting development, candidate sourcing, interviewing, selection processes, process documentation, compliance management, and status communication with candidates and hiring managers.
2. Assist with the development of the recruitment and candidate sourcing strategy, establish priorities, strategies and metrics to ensure alignment with business/functional strategy
3. Actively participates in recruiting/hiring related projects or initiatives with businesses/functions areas
4. Manages respective candidate pools to ensure qualified candidates remain engaged in current or future opportunities and ensure a strong and positive client and candidate experience.
5. Primary responsibility to report status (completed items/projects, issues/potential issues) related to Hiring and Recruiting
6. Primary responsibility to communicate area updates clearly and effectively
7. Responsible for driving communication and follow up of area specialty
8. Reach out to other area owners to keep all informed.
9. Live our core values through excellent Communication, Teamwork, and Leadership.

Education/Experience Requirements for Human Resources Specialist:

• B.S. Engineering or related discipline
• Prefer candidates with recruiting experience and excellent communication skills

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Description for Molding Process Engineer:

This position will support product design and process development activities for extruded/molded products that are in compliance with all quality and regulatory requirements. This is a full-time, on-site position. This role is an Independent Contributor role. There are no direct reports for this position. Interaction is potentially with all levels of the organization.

Responsibilities for Molding Process Engineer:

• Support lead engineer in managing transfers between vendors as necessary, including tool, process, and product specifications and incoming inspection plans.
• Design experiments to provide data based conclusion about a process or product performance.
• Write technical reports detailing procedures, outcomes, and observations
• Interface with internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.
• Develop transfer equivalency justification; including hands on testing of final product parts to ensure product release and properties meet established specifications.
• Support new equipment/process implementation using process validation techniques.
• Prepare validation protocols and reports, including IQ/OQ/PQs as necessary.
• Assist in test method development and analytical equipment as requested.
• Assist in establishing final part inspection including evaluation of sample size, test methods, and defect criteria.
• Provide input to risk assessment activities such as FMEA.

Required/Preferable Knowledge, Skills and Abilities for Molding Process Engineer:

Required:

• Excellent organizational skills, attention to detail, ability to manage time and prioritize.
• Ability to think proactively, troubleshoot, investigate and improve systems.
• Ability to be a team player.
• Excellent communication and interpersonal skills, able to interact w assertively with people at all levels of the organization.
• Ability to undertake key project tasks and train others as required.
• Understanding of statistical methods and associated statistical analysis software.
• Excellent technical writing skills, grammar, proof reading skills.

Preferred:

• Experience with polymer extrusion/ injection and or silicone molding / ultrasonic welding / 3D design – SolidWorks.
• Experience with Minitab or other statistical software packages.

Education/Experience Requirement:

Required: Bachelor of Science degree or higher in Engineering, preferably Plastics or Materials Engineering.

Preferred: 1-2 years of experience in medical device, pharmaceutical or similarly cGMP/ISO regulated industry

Environmental Requirements:

Must be able to adapt to multiple indoor work environments (shared office space, shared lab space and production areas).

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment is mandated. The employee is frequently exposed to moving mechanical parts; with some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a full benefits package including vacation time. The Poly-Med, Inc. pay cycle is monthly.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

This position will implement product design and process development activities for extruded products with compliance to all quality and regulatory requirements. This is a full-time, on-site position. This role is an Independent Contributor role. There are no direct reports for this position. Interaction is potentially with all levels of the organization.

​Responsibilities for the Extrusion Engineer:

Interface with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.

• Project member for new design and development teams of medical fibers, tubes, films, or blend extrusion.
• Provide technical expertise to improve process efficiency/product quality.
• Support new equipment/process implementation.
• Conduct process validation activities following IQ/OQ/PQ techniques.
• Provide cost-saving initiatives by evaluating manufacturing processes while maintaining quality standards.
• Create and analyze prototype products.
• Design experiments to provide data based conclusion about a process or product performance.
• Recommend and rationalize specifications for development products.
• Develop test methods for evaluation of new products following applicable standards such as ASTM or ISO
• Implementation of process improvements and monitoring for efficacy.
• Assist with implementing corrective actions (CAPA) with QA.
• Operate processing equipment in a specific process area.
• Conduct analytical techniques with the ability to interpret results for project recommendations.
• Lead and provide input to risk assessment activities such as FMEA.
• Assist in creation of publishable research findings in the form of abstracts, papers and grants.
• Support patent filing and claims.
• Write technical reports detailing procedures, outcomes, and observations.

Required/Preferable Knowledge, Skills and Abilities for Extrusion Engineer:

• Must have experience with extrusion and fiber processing techniques for single or twin screw extrusion.
• Prior experience with medical fibers and textiles preferred, especially bioabsorbable/bioresorbable materials.
• Prior experience working in an ISO 9001, ISO 13485, or GMP facility.
• Ability to handle confidential business information.
• Understanding of statistical methods and associated statistical analysis software. Preferred experience with Minitab
• Understanding of cause-effect relations between process inputs and product specifications.
• Understanding of the effect of a process on downstream steps or customer needs.
• Ability to design experiments and evaluate data using polymer, fiber, and textile characterization techniques (tensile, burst, tear, porosity, DSC, GPC, viscosity, MFI, melt rheology etc).
• Ability to be a team player.
• Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.

Education/Experience Requirements for Extrusion Engineer:

Required- Bachelor’s Degree with 1 – 3 years industry experience

Working Conditions at Poly-Med, Inc.:

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals. Employees must be able to adapt to indoor work environment. The following physical requirements can include: sitting, standing, walking, climbing/balancing, reaching, stooping/kneeling/crouching/crawling, talking, hearing, feeling/touching, vision (close, peripheral, depth, ability to adjust focus).

Poly-Med, Inc. offers a great selection of benefits including vacation time.

Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

This position will implement product design and process development activities with compliance to all quality and regulatory requirements.

Responsibilities for the Biomaterials Engineer:

• Interface with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.
• Project member for new design and development teams.
• Provide technical expertise to improve process efficiency/product quality.
• Support new equipment/process implementation.
• Conduct process validation activities.
• Provide cost-saving initiatives by evaluating manufacturing processes while maintaining quality standards.
• Create and analyze prototype products.
• Design experiments to provide data based conclusion about a process or product performance.
• Design products, equipment or fixtures using CAD techniques.
• Recommend and rationalize specifications for development products.
• Develop test methods for evaluation of new products.
• Implementation of process improvements and monitoring for efficacy.
• Assist with implementing corrective actions (CAPA) with QA.
• Procure new testing and manufacturing equipment using IQ/OQ/PQ process validation techniques.
• Operate processing equipment in a specific process area.
• Conduct analytical techniques with the ability to interpret results for project recommendations.
• Lead and provide input to risk assessment activities such as FMEA.
• Assist in creation of publishable research findings in the form of abstracts, papers and grants.
• Support patent filing and claims.
• Write technical reports detailing procedures, outcomes, and observations.

Required/Preferable Knowledge, Skills and Abilities for the Biomaterials Engineer:

• Ability to handle confidential business information.
• Understanding of statistical methods and associated statistical analysis software.
• Understanding of cause-effect relations between process inputs and product specifications.
• Understanding of the effect of a process on downstream steps or customer needs.
• Ability to design experiments and evaluate data.
• Ability to be a team player.
• Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.

Education/Experience Requirements for the Biomaterials Engineer:

Required- Bachelor’s Degree with 0-2 years industry experience

Preferred – Industry experience with materials testing and characterization.

This position will implement product design and process development activities with compliance to all quality and regulatory requirements.

Responsibilities for the Biomaterials Engineer:

• Interface with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.
• Project member for new design and development teams.
• Provide technical expertise to improve process efficiency/product quality.
• Support new equipment/process implementation.
• Conduct process validation activities.
• Provide cost-saving initiatives by evaluating manufacturing processes while maintaining quality standards.
• Create and analyze prototype products.
• Design experiments to provide data based conclusion about a process or product performance.
• Design products, equipment or fixtures using CAD techniques.
• Recommend and rationalize specifications for development products.
• Develop test methods for evaluation of new products.
• Implementation of process improvements and monitoring for efficacy.
• Assist with implementing corrective actions (CAPA) with QA.
• Procure new testing and manufacturing equipment using IQ/OQ/PQ process validation techniques.
• Operate processing equipment in a specific process area.
• Conduct analytical techniques with the ability to interpret results for project recommendations.
• Lead and provide input to risk assessment activities such as FMEA.
• Assist in creation of publishable research findings in the form of abstracts, papers and grants.
• Support patent filing and claims.
• Write technical reports detailing procedures, outcomes, and observations.

Required/Preferable Knowledge, Skills and Abilities for the Biomaterials Engineer:

• Ability to handle confidential business information.
• Understanding of statistical methods and associated statistical analysis software.
• Understanding of cause-effect relations between process inputs and product specifications.
• Understanding of the effect of a process on downstream steps or customer needs.
• Ability to design experiments and evaluate data.
• Ability to be a team player.
• Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.

Education/Experience Requirements for the Biomaterials Engineer:

Required- Bachelor’s Degree with 0-2 years industry experience

Preferred – Industry experience with materials testing and characterization.

Entry-level position responsible for supporting a wide variety of quality-related activities and tasks under general supervision and guidance. Primary job functions do not typically require exercising independent judgment.

Scope for Quality Specialist:

This role is an Independent Contributor role; there are no direct reports for this position. Interaction is potentially with all levels of the organization. This position reports to a Quality Engineer or the Quality Assurance Manager. Responsibilities will apply to performance of this role at any Poly-Med location, as assigned by management.

Responsibilities for Quality Specialist:

1. Seeks resolution to issues encountered during the course of routine quality duties.
2. Supports multiple aspects of compliance for the Quality System as needed.
3. Assists with NCRs, Investigations, QC requests, IPs, SOPs, CAPAs, and ECOs as directed by a more senior QS or management.
4. Monitor manufacturing processes and GDP compliance, as directed.
5. QC Support Sample Tracking- Work with Manufacturing and QC to ensure samples are properly received, logged, and tracked. Also perform QC review and verification in EIQ.
6. Environmental Monitoring (temperature, humidity, bioburden and non-viable particulate) throughout buildings and in Cleanroom as requested.

Responsibilities for Quality Specialist regarding Calibrations Support:

1. In house and Out of house calibrations – Assist calibration coordinator with activities for the site.
2. Calibration records– Keep paper files of all calibration records and certificates and update the calibration database as required.
3. Site Calibrated equipment – Secure the calibration equipment cabinet. With the calibration coordinator, keep stock of routinely calibrated and replaced items.

Other General Responsibilities for Quality Specialist:

1. Conform to all SOPs associated with the position and submit ECO for changes if updates or revisions are needed.
2. Perform additional duties as assigned by Management.
3. Provide backup assistance to Document Control common functions such as issuing documents, shipment verifications, internal auditing, third party audit assistance, MI review and approval, scanning and archiving.

Education/Experience Requirements for Quality Specialist:

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Description:

The IT Support Specialist will assist the IT Systems Administrator with install, monitor, repair, maintain, and upgrading Poly-Med, Inc.’s network and computer system.

Responsibilities:

• Responsible for installing network and computer systems.
• Responsible for maintaining, repairing, and upgrading network and computer systems.
• Diagnosing and troubleshooting potential network problems.
• Monitors network and systems to improve performance.
• Creates, maintains, and organizes backups (onsite and offsite).
• Ensures security and integrity of all company data.
• Ensures all devices are properly updated.
• Assists in the planning and preparation for future projects/upgrades.
• Performs logging of backups.
• Participates in continuous education of technological changes and advancements.
• Responsible for the assignment and tracking of all company devices (computers, routers, switches, phones, printers, scanners).
• Building Access system tasks
• Phone Systems tasks
• Oversee maintenance, upgrades, and backups to analytical workstations.
• Responding to Help Desk Tickets

Required/Preferable Knowledge, Skills and Abilities

Microsoft Domain Environment

• Active Directory
• Group Policy
• RDS/Terminal Services
• Office 365 Exchange Online
• Office 16 Suite
• Powershell
• VBA
• IIS
• SQL/MySQL/Oracle
• Windows XP, 7, and 10
• Server 2008, Server 2012 Std/R2, Server 2016

VMware 6.5

• Host and SAN environment
• Veeam Backup Solutions

Networking Devices

• General Knowledge of Routing and Switching/Networking Protocols
• TCP/IP
• Subnets
• Cable making skills
• Dell/Netgear PoE Switches
• Ubiquiti Systems
• VPN
• Fortinet

VoIP

• AVAYA System

PC Hardware Maintenance Knowledge

Network Security

• Firewall
• Security Policies

Excellent Soft Skills

Java and VB experience/skills a plus

SharePoint Database administration experience a plus.

Education/Experience Requirements:

Required: Associates Degree in Network Administration

Preferred: 2 – 5-years’ experience in Network Administration and/or Help Desk, Current A+; Current Network +

Environmental Requirements:

Must be able to adapt to multiple indoor work environments (shared office space, shared lab space and production areas).

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

The Quality Control/Analytics Technician is an entry-level position requiring one or more years of relevant experience. This role will perform testing on absorbable polymeric components for medical device applications.

Responsibilities:

• Perform mechanical and analytical testing of polymeric materials for QC, direct customer requests or for internal projects.
• Write internal memos, reports, and other documents as needed.
• Perform other Quality Control and QA functions including calibration, daily environmental monitoring, and other activities to ensure compliance to GMPs and ISO 13485.
• Seeks resolution to issues encountered during the course of routine testing.
• Perform unbiased, in-process, and finished goods testing according to standardized procedures as required to support product realization.
• Support safety initiatives and compliance.
• Perform lab housekeeping and organization as needed.
• Additional duties may be required as assigned by management.

Required/Preferable Knowledge, Skills and Abilities:
Minimum Associate Degree in Chemistry and 1 year laboratory experience.

Experience with HPLC, GPC, GC, Inherent Viscosity, Tensile testing, DSC, TGA, and/or FTIR preferred.

• Dependable
• Detail oriented
• Organized and efficient
• Ability to follow written and verbal instructions with repeatable and accurate results
• Excellent communication and data recording ability
• Strong math skills and ability to perform calculations as needed
• Must be very detail-oriented and appreciate the value of accuracy
• Ability to deal effectively with time pressures, stress, and changing demands of job on a regular basis.

Working Conditions at Poly-Med, Inc.:

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

About Us:

Poly-Med is the leading developer of bioresorbable polymers and fibers. We help innovative medical device companies focused on improving patient outcomes. Poly-Med designs, develops and manufactures superior materials to get customer products to market in the most efficient manner with the greatest improvement to quality of life. Located in Anderson, South Carolina, Poly-Med, Inc. has been recognized as a leader in the industry for over 20 years. Poly-Med continues to grow in a multitude of medical device modalities. Our novel materials are key in actively enabling products ranging from vascular stents, hernia meshes, dental delivery systems, dental hygiene, and a variety of wound closure applications in the worldwide medical device market.

For additional information, visit our website at www.Poly-Med.com.

Our Team:

We employ a widely diverse team comprised of experts from material science, chemical engineering, mechanical engineering, bioengineering, biology, business marketing, and project management to create a work environment focused on solving tough medically related problems. Our team is energetic, resourceful, and, above all, collaborative. We are searching for like-minded talent to build on our success and continue our quest to improve patient outcomes through novel polymeric and drug delivery systems.

Description:

This position is self-directed and is responsible for performing quality assurance tasks and activities with minimal guidance and supervision. Has broad knowledge of commonly used concepts, practices, and procedures within Quality Assurance field. Relies on personal experience and judgment to perform primary job responsibilities.

Responsibilities:

• Support document management and maintenance, including ECO system, lab notebook management and document archival duties in its various forms.
• Responsible for training records management.
• Performs basic clerical duties as required to ensure compliance to ISO 13485 and 21 CFR part 820.
• Seeks resolution to issues encountered during the course of routine quality duties.
• Supports multiple aspects of compliance for the Quality System as needed.
• Participates in internal auditing.
• Responsible for document management and maintenance functions, including batch cards, MIs, DHR, DMR, escrow, DMF, NCR, CAPA, and Label Control.
• Coordinates and plans required documentation for product realization and shipments.
• Makes suggestions for improvements to current documentation processes and systems.
• Provides critical reviews of all PMI documentation as required.
• May be crossed trained for executing calibrations, validations, QC testing or reviews and environmental monitoring.
• Participates in internal auditing. May also be required to be a lead auditor.
• Performs other duties as assigned.

Required/Preferable Knowledge, Skills and Abilities:

Required: High School Diploma and up to a year of experience or

Preferred: Associate’s Degree in science major OR 2 – 4 years of professional experience preferably in medical device, pharmaceutical or similarly regulated industry.

• Proficiency in Microsoft Office Software (Microsoft Word, Excel, et. al.)
• Excellent organizational skills
• Ability to assertively interact with people at all levels of the organization
• Good technical writing skills, grammar
• Ability to manage time and prioritize, as well as multi-task
• Ability to handle highly confidential business information
• Strong attention to detail
• Ability to think proactively
• Ability to look at processes and make suggestions for improvements

Education/Experience Requirements:

Required- Associate’s Degree or equivalent applicable professional work experience

Preferred- Previous experience working in document control

Working Conditions at Poly-Med, Inc.:
This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.
Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.
Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

The Account Manager is responsible for multiple Poly-Med accounts, outlined on customer and project trackers. This position works with other members of the business development team and company as a whole to develop new opportunities through existing clients and developing new clients. Specifically, this employee is responsible for growing revenue related to their specific clients and helping those clients bring their products to market.

Responsibilities:

• Generate revenue by discussing, preparing and executing proposals with customers.
• Develop current accounts through efficient follow through as well as exploration of other synergistic activities between companies.
• Interact with Sales to develop new clients and identify key decision makers to communicate with.
• Interface with Product Managers to continually develop product lines based on experience with clients.
• Develop and maintain consistent communication and delivery with accounts.
• Ensure customer satisfaction and success while managing Poly-Med interests such as intellectual property project profitability etc.
• Will participate in lab work as needed
• Assist with and ensure continuity in contractual agreements with accounts

Required/Preferable Knowledge, Skills and Abilities

• Organized
• Team Player
• Confident
• Can easily communicate with individuals with various levels of technical experience
• Effective presentation skills
• Ability to facilitate small groups
• Logical and critical thinking
• Expert problem-solver
• Ability to influence and persuade
• Ability to handle multiple and competing priorities
• Ability to balance big-picture view with details and issues

Education/Experience Requirements:

Required- MS degree in an engineering discipline or material science and 2-5 years of experience.

Preferred- Ph.D. in a related science or engineering discipline and 2-5 years of experience.

Working Conditions at Poly-Med, Inc.:

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Position Summary:

Poly-Med, Inc. is seeking candidates that have experience with working in a fast past environment; are motivated, enthusiastic, and works well in both a team and individual setting. Our polymer laboratory technicians play a critical role in the manufacturing process of creating our products. This position does involve physical/manual labor. Candidates with experience in restaurants as either a waiter or waitress will make the ideal candidate. Please read all requirements prior to applying.

Responsibilities:

• Maintaining the manufacturing area including cleaning of glassware, waste management, transfer of materials to and from inventory, keeping track of raw material consumption, and general housekeeping including maintenance of equipment.
• Batch manufacturing to include weighing and charging raw materials to vessels, transferring products from vessels to storage containers, and product processing.
• Use a variety of machinery and tools to complete daily tasks including grinder, sieve, hammer, chisel and similar accessories and equipment found in a laboratory.
• Read, record and interpret data from instruments, reactors, pumps, etc. to adjust as required to affect efficient and safe operations.
• Understand the key process variables which impact product and quality/consistency
• Follows company policies, principles, procedures, standards, and practices to ensure safe and reliable operation.
• Contributes towards the positive and energetic culture
• Fully support Poly-Med’s goals of zero workplace safety incidents and participates in EHS programs
• Performs related duties as assigned.

Required/Preferable Knowledge, Skills and Abilities

• Positive Attitude
• Attention to details
• Time Management – must be able to balance multiple processes at once.
• Ability to listen and communicate effectively
• Experience in the food service industry is helpful.
• Willingness to learn, listen to directions and accept guidance.

Education/Experience Requirements:

Required: High School Diploma or GED

Preferred: High School Diploma with an interest in Science and has some lab experience.

Environmental Requirements:

Must be able to adapt to multiple indoor work environments (shared office space, shared lab space and production areas).

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.