What are the responsibilities and job description for the Quality Manager - Medical Device position at 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.
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.
- Lead risk management activities (ISO 14971).
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.
- Strong communication skills.
- Supplier quality and electronic document control experience preferred.