Quality Assurance & Regulatory Affairs Director
Fast growing ISO 9001 & 13485 certified US Manufacturer and global leader in medical grade compression apparel with history & commitment to scientific testing & innovation. Products range from high-performance compression garments that range from post-surgery to everyday shapewear to athletic apparel. Private Equity ownership with open and friendly/family like environment. Benefits include 401K (eligibility after 1 month of employment, with company matching), Group Medical/Dental/Vision, company paid life insurance, company paid ST and LT disability insurance, and unlimited PTO!
The Director of QA/RA oversees company’s global quality system compliance function and related processes. Ensures that company’s programs and processes are in adherence to the latest regulatory requirements and industry trends, and manages the applicable local, state, federal, and international inspections governing Class 1 medical devices (post-surgical compression garments). Provides direction to Quality Systems and Compliance, Documentation/Training responsibilities, complaint handling and any associated field actions. Develops and communicates corporate quality metrics to help drive process and quality culture improvements. Conduct and maintain management review of the Quality system and function. This position leads a team/supervises a Quality Manager, QA Specialist & RA specialist. Travel requirements estimated at 15%
- BS/BA degree in a related medical, science or business discipline or equivalent training and formal experience
- 7+ years in ISO and FDA regulated environment (GMP, MDR, QSR, ISO 13485, ISO 9001)
- 5+ years of professional Quality experience
- 5+ years in a supervisory/management position
- Extensive hands-on experience with Quality Management Systems, performing CAPAs, Failure Investigation and Management Review
- Ability to coordinate and lead teams to resolve technical issues
- Textile manufacturing experience is preferred
All Candidates must be able to provide work related references.
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Included in this industry are the apparel, home furnishings and industrial markets. We work in the fiber, fabric and fashion industry with clients and candidates located all over the world.
All candidates must be able to provide work related references.
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