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.
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.
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.
- 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
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.