Medical Device Engineer / Quality Manager

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.

We're looking for either an engineer with strong quality management experience or a quality leader with a solid engineering toolkit. We need someone to take over the role of Management Representative and own all the typical Quality Manager responsibilities in regards to the QMS (CAPAs, Complaints, NCMRs, Internal Audits, Management Reviews, etc.). But we also need some additional support in what an engineering role would typically be : DHFs, ECOs, managing testing and writing test reports, managing supplier and component approvals / specifications, etc.

We have strong consultant and internal support / expertise in all areas but simply cannot handle the workload. We do not expect any given candidate to satisfy all requirements. We are looking for someone who can take the lead on the following initiatives, with significant support provided, and ensure proper execution of all deliverables

RESPONSIBILITIES AND DUTIES :

Quality System / Leadership

• 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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