Next Level Impacts
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.
Location:
Tampa, FL
Salary:
$160,000–$175,000
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.
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Location:
Tampa, FL
Salary:
$160,000–$175,000
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.
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