Medical Device Engineer / Quality Manager

Overview

Apex Biologix - We are a regenerative medicine company, providing high-quality biologic medical supplies and equipment to physicians and clinics nationwide. We are a fast-growing company in an evolving industry with projections to substantially increase our operations and sales this year.

Responsibilities and Duties

• Assume the role of Management Representative : Own and maintain a lean, pre-existing, audit-ready QMS aligned to ISO 13485 and the FDA QMSR transition (from 21 CFR Part 820); maintain / update SOPs, forms, and training.
• Lead internal audits, supplier audits, management reviews, quality objectives, and KPIs (e.g., yield, complaints / 1,000 units, OTD, NCMR / ECO / CAPA cycle time).
• Oversee document control, training effectiveness, and change control (ECOs / Deviations), ensuring risk-based decisions and full traceability.
• Mentor and develop quality techs.
• Qualify and monitor CMs, sterilizers, and packaging suppliers (SCARs, QBRs, performance scorecards).
• Partner with Operations and R&D on DHF, verification / validation test plans, and cost-of-quality reductions without compromising safety or compliance.
• Partner with Operations to ensure efficient production, training, compliance, and documentation (Work Instruction development, record keeping, etc.).

Product Engineering

Requirements

Additional Skills

Pay and Benefits

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