Medical Device Engineer/Quality Manager

Job description

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

• Lead phase-gated design controls, properly document in the DHFs, plan/execute/document design verification testing.
• Manage/maintain/update the Risk Management Files and FMEAs. Maintain product risk management to ISO 14971 across design/process/post-market; link hazards ↔ controls ↔ verification.
• Manage change control/ECOs with risk-based regulatory impact assessments.
• Develop statistically sound sampling plans (ANSI/ASQ Z1.4 / ISO 2859-1); drive root cause analysis (5-Why, Ishikawa, DOE) and corrections.
• Review and release DHRs/lot records; define acceptance criteria, trending, and lot-release dashboards.
• Own sterilization lifecycle with partners: ISO 11135/37 validations, quarterly/annual requalification, bioburden/BI oversight, and SAL justification.
• Own packaging system lifecycle under ISO 11607-1/-2: seal strength (ASTM F88), dye/bubble leak (ASTM F1929/F2096), distribution integrity (ASTM D4169 / ISTA 3A), aging studies, label/IFU durability, and shelf-life claims.
  
  Ensure complaint-driven re-assessment of worst-case packaging and sterile barrier systems.
• Ensure compliant UDI/labeling (21 CFR 801), IFUs, and claims; partner with Regulatory on submissions and change assessments.

REQUIREMENTS:

• 7+ years in medical devices with increasing responsibility across Quality and/or Manufacturing/Process/Packaging Engineering (small-company experience a plus).
• Hands-on ownership of: ISO 13485, ISO 14971, ISO 11135/37, ISO 11607, and distribution testing.
• Comfortable reviewing DHRs/batch records, various trending dashboards; strong writing for procedures, reports, and investigations.
• Audit experience (internal, supplier, and at least one external: Notified Body or FDA/Health Canada).
• Working knowledge of biocompatibility basics (ISO 10993), label controls/UDI, and complaint/MDR pathways.
• Clear understanding of EtO and Gamma sterilization processes and their impacts to product design and packaging selection.
  
  

ADDITIONAL SKILLS:

• Sterile kit experience; contract manufacturing and sterilization management.
• Specific engineering background (mechanical design, packaging tooling and pouch/tray/label specs, process engineering).
• Qualification of cleanroom environments and environmental monitoring programs.
• Knowledge of importing and FDA customs importing/exporting.
• Some understanding of MDSAP compliance and implementation over an existing ISO 13485 foundation.
  
  
• OUS device listing/registration experience.
• CAD experience such as SolidWorks, Inventor or even SketchUp.
  
  
• Statistical analysis
• Scientific method, human cell biology and chemistry.
  
  
• Worked on any studies relate to medical devices or drugs.
  
  

PAY AND BENEFITS:

• Salary-W2 Position
• Health, dental, vision and life benefits available
• 401K matching
• 120 hours of Paid time off

Required Skill Profession

Operations Specialties Managers