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 Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Medical Equipment Manufacturing, Manufacturing, and Hospitals and Health Care
Get notified about new Quality Assurance Manager jobs in
Naples, FL .
#J-18808-Ljbffr
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 Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Medical Equipment Manufacturing, Manufacturing, and Hospitals and Health Care
Get notified about new Quality Assurance Manager jobs in
Naples, FL .
#J-18808-Ljbffr