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Senior Quality Engineer – Medical DevicesAvenue 45 • Mississauga, Peel Region, Canada
Senior Quality Engineer – Medical Devices

Senior Quality Engineer – Medical Devices

Avenue 45 • Mississauga, Peel Region, Canada
6 days ago
Job type
  • Full-time
Job description

Senior Quality Engineer – Medical Devices

Onsite role, Monday – Friday

Employment Type: Full-Time

Our direct client is a Senior Quality Engineer to join an innovative medical device organization developing cutting-edge diagnostic technologies. This is a highly visible, hands‑on role focused on supporting manufacturing operations and partnering closely with R&D to successfully transfer new products into production.

This is an excellent opportunity for a seasoned Quality Engineer who thrives in a manufacturing environment and enjoys taking ownership of process improvements, validations, and product commercialization.

Required Qualifications

  • 10+ years of Quality Engineering experience within the medical device industry.
  • Strong manufacturing quality experience (preferred over product design quality).
  • Proven experience supporting design transfer from R&D into manufacturing.
  • Experience with process validations, test methods, characterization studies, and process capability.
  • Experience working with supplier quality and manufacturing engineering teams.
  • Experience with medical device hardware/instrumentation is required.
  • Excellent problem‑solving, communication, and cross‑functional collaboration skills.

Nice to Have

  • Experience with diagnostic medical devices.
  • Experience supporting assay-based products or IVD technologies.

Key Responsibilities

  • Partner with R&D teams on design transfer activities and new product introductions.
  • Lead quality engineering efforts to support manufacturing scale‑up and production readiness.
  • Develop and improve test methodologies and product characterization activities.
  • Conduct process capability studies and analyze manufacturing data to drive continuous improvement.
  • Lead equipment, process, and product validation activities (IQ/OQ/PQ).
  • Collaborate with Manufacturing Engineering to optimize production processes.
  • Support supplier quality initiatives, including supplier qualification and performance improvement.
  • Ensure compliance with quality system requirements and applicable medical device regulations.
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Senior Quality Engineer – Medical Devices • Mississauga, Peel Region, Canada

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