Next Level Impacts
3 days ago Be among the first 25 applicants
Direct message the job poster from Next Level Impacts
Recruiter - Executive Search | Diagnostics | Medical Device | Life Science | Nutraceutical | Talent Expert for Sales, Marketing, Clinical Affairs…
Ready to lead quality excellence in a fast-moving, innovation-driven environment? We're searching for a Quality Manager to own product quality, strengthen the Quality System, and drive cross-functional compliance from design through distribution. Responsibilities Own core Quality System processes (CAPA, DHR/DMR, calibrations, design transfer/changes, MRB). Lead the U.S. site quality team and maintain audit readiness. Support quality activities from development through manufacturing and distribution. Lead investigations, root-cause analysis, and continuous improvement efforts. Oversee sterilization validation, environmental monitoring, and QMS compliance. Partner with cross-functional teams including Operations, Engineering, R&D, and Supply Chain. Manage supplier qualification, monitoring, and first-article inspections. Qualifications Bachelor’s degree and 5–7 years of medical device experience. Strong knowledge of ISO 13485, ISO 14971, 21 CFR 820 (QSR/QMSR), and EU MDR. Experience with audits, design transfer, design changes, and risk management. Supplier quality and electronic document control experience preferred. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Medical Equipment Manufacturing, Manufacturing, and Hospitals and Health Care Referrals increase your chances of interviewing at Next Level Impacts by 2x Get notified about new Quality Assurance Manager jobs in
Sarasota, FL . Bradenton, FL $60,000.00-$60,000.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Ready to lead quality excellence in a fast-moving, innovation-driven environment? We're searching for a Quality Manager to own product quality, strengthen the Quality System, and drive cross-functional compliance from design through distribution. Responsibilities Own core Quality System processes (CAPA, DHR/DMR, calibrations, design transfer/changes, MRB). Lead the U.S. site quality team and maintain audit readiness. Support quality activities from development through manufacturing and distribution. Lead investigations, root-cause analysis, and continuous improvement efforts. Oversee sterilization validation, environmental monitoring, and QMS compliance. Partner with cross-functional teams including Operations, Engineering, R&D, and Supply Chain. Manage supplier qualification, monitoring, and first-article inspections. Qualifications Bachelor’s degree and 5–7 years of medical device experience. Strong knowledge of ISO 13485, ISO 14971, 21 CFR 820 (QSR/QMSR), and EU MDR. Experience with audits, design transfer, design changes, and risk management. Supplier quality and electronic document control experience preferred. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Medical Equipment Manufacturing, Manufacturing, and Hospitals and Health Care Referrals increase your chances of interviewing at Next Level Impacts by 2x Get notified about new Quality Assurance Manager jobs in
Sarasota, FL . Bradenton, FL $60,000.00-$60,000.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr