Quality Assurance / Regulatory Affairs Manager

WHAT YOU WILL DO

• Lead, coach, and develop the Quality team across Quality Engineering, Quality Systems, Regulatory Affairs, and Quality Control.
• Manage and continuously improve the ISO 13485:2016 and MDSAP-aligned Quality Management System .
• Lead internal and external audits, including MDSAP, Health Canada, and customer audits.
• Oversee CAPA, root cause investigations, nonconformances, supplier quality, and corrective actions.
• Ensure compliance with Health Canada Medical Devices Regulations (SOR/98-282) , including licensing and post-market reporting.
• Oversee product and process risk management in accordance with ISO 14971.
• Support process validation (IQ/OQ/PQ), design changes, and design transfer activities.
• Manage quality inspections, product release, calibration, and manufacturing quality activities.
• Oversee complaint handling, post-market surveillance, recalls, and regulatory reporting.
• Collaborate with Manufacturing, Engineering, and senior leadership to strengthen quality performance and compliance.

WHAT WE'RE LOOKING FOR

Required Qualifications

• Bachelor's degree in Engineering, Science, or a related technical field, or an equivalent combination of education and experience.
• Minimum 7 years of progressive experience in medical device Quality Assurance and/or Regulatory Affairs.
• Demonstrated experience managing quality professionals and/or supervisors.
• Strong knowledge of ISO 13485, MDSAP, and Health Canada Medical Devices Regulations .
• Experience managing QMS activities, internal and external audits, CAPA, and root cause investigations.
• Knowledge of medical device regulatory compliance, licensing, and post-market reporting.
• Strong communication, problem-solving, organizational, and leadership skills.
• Ability to work 100% on-site in Markham, Ontario .

Preferred Qualifications

• ASQ certification (CQE, CQA, CMQ/OE) or RAPS Regulatory Affairs Certification (RAC).
• ISO 13485 Lead Auditor training or certification.
• Lean Six Sigma certification.
• Experience with EU MDR 2017/745 and international medical device regulatory requirements.
• Experience with supplier quality, ISO 14971 risk management, and manufacturing quality operations.

COMPENSATION & WORK ENVIRONMENT

• Annual Salary: $110,000–$125,000 CAD
• Full-time, permanent position.
• 100% on-site at the Markham, Ontario facility.
• Combination of office and manufacturing floor responsibilities.
• Approximately 10% travel for audits, supplier visits, and corporate activities.
• Opportunity to lead a multidisciplinary Quality team and contribute directly to product safety, regulatory compliance, and operational performance.

INTERESTED IN THIS OPPORTUNITY?

Are you an experienced medical device quality professional looking for your next career opportunity? Or perhaps you know someone who would be a great fit?

I'd love to connect!

Apply directly, reach out to me through LinkedIn, or feel free to share this opportunity with someone in your professional network.

Sabrina Olivier

Bilingual Recruiter | Science, Engineering & Technology

Kelly Services