Sr./Lead Quality System Specialist - LEXINGTON, MA
The Select Group is looking for an experienced Quality System Specialist for one of our clients in Lexington, MA!
QUALITY SYSTEM SPECIALIST REQUIREMENTS
Experience dealing with customer complaints (complaint handling)
Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807)
3+ years' experience with quality system support activities in an FDA regulated environment
Experience with CAPA Management System
QUALITY SYSTEM SPECIALIST DAILY RESPONSIBILITIES
- This position supports full, ongoing compliance to all applicable FDA medical device regulatory requirements
- Following MDR procedures and complaint investigation
- Determine Medical Device Reportability
- Perform internal audits and external supplier audits
- Perform corrective and preventative action on non-conforming products
About The Select Group:
We are TSG - a fast-growing technical services firm serving the U.S. and Canada. We open doors to diversified prospective employers who respect and value your ambitions, your pursuit of a meaningful career, and your particular skill-set. We offer interview guidance, an impressive referral program, and partner with you to find work that drives you. Learn more about us in our URL blocked - click to apply or visit us at URL blocked - click to apply Sign up to receive weekly job alerts in your inbox by joining the URL blocked - click to apply
We have the privilege of impacting lives, so let us impact yours.
The Select Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.
Corrective And Preventive Action (Capa)
Quality Management Systems
Title 21 Of The Code Of Federal Regulations
Medical Device Reporting