Medical Device Quality Assurance Manager

Lead medical device quality assurance in Markham, Ontario, overseeing ISO 13485, MDSAP, audits, and regulatory compliance fully on-site.

Kelly Services is recruiting an experienced QA/RA Manager for an established medical device manufacturer. You will lead Quality Engineering, Quality Systems, Regulatory Affairs, and Quality Control. The position oversees the QMS, audits, CAPA, risk management, and Health Canada requirements.

Key Responsibilities:

• Lead, coach, and develop the multidisciplinary Quality team
• Improve the ISO 13485:2016 and MDSAP-aligned QMS
• Lead MDSAP, Health Canada, and customer audits
• Oversee CAPA, root cause investigations, and nonconformances
• Manage product release, calibration, and manufacturing quality activities

Requirements:

• Bachelor’s degree in Engineering, Science, or related technical field
• Minimum seven years’ progressive medical device QA and/or RA experience
• Experience managing quality professionals and/or supervisors
• Strong knowledge of ISO 13485, MDSAP, and Health Canada regulations
• Ability to work 100% on-site in Markham, Ontario

Apply medical device quality leadership, QMS expertise, and audit experience while supporting compliance and product safety in Markham.

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