Medical Device Quality Engineer & Compliance

Myant Inc.

Mississauga

Sur place

CAD 85 000 - 120 000

Plein temps

Il y a 7 jours
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Résumé du poste

Myant is seeking a Quality Engineering Specialist to strengthen manufacturing processes, supplier quality and quality systems within a regulated medical device environment. The role focuses on quality assurance, process validation, CAPAs and risk management to ensure compliant, high‑quality production.

Ideal candidates will have a strong quality engineering background in medical devices, experience with ISO 13485/EU MDR, and hands-on capability to drive improvements across Manufacturing and

Qualifications

  • Bachelor's degree in Engineering or related technical discipline required.
  • Strong quality engineering knowledge in medical devices advantageous.
  • Proven ability to apply quality systems and regulatory requirements.

Responsabilités

  • Lead quality engineering activities in a regulated medical device environment.
  • Develop, review and approve validation protocols and reports for manufacturing equipment and processes.
  • Lead or participate in FMEA and CAPA activities to reduce risk and improve quality.
  • Support supplier quality management and audits to ensure compliance.
  • Collaborate with Manufacturing, Engineering and Regulatory teams to drive improvements.

Formation

Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, Life Sciences or a related technical discipline

Description du poste

Myant is seeking a Quality Engineering Specialist to strengthen manufacturing processes, supplier quality and quality systems within a regulated medical device environment. The role focuses on quality assurance, process validation, CAPAs and risk management to ensure compliant, high‑quality production.

Ideal candidates will have a strong quality engineering background in medical devices, experience with ISO 13485/EU MDR, and hands-on capability to drive improvements across Manufacturing and

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