Talent.com
Medical Device Engineer/Quality Manager
Medical Device Engineer/Quality ManagerZipRecruiter • Woods Cross, UT, US
Medical Device Engineer / Quality Manager

Medical Device Engineer / Quality Manager

ZipRecruiter • Woods Cross, UT, US
job_description.job_card.1_day_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

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

  • 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

    • J-18808-Ljbffr

    serp_jobs.job_alerts.create_a_job

    Manager Medical Device • Woods Cross, UT, US