Quality Assurance / Regulatory Affairs Manager

Kelly; Markham; On-site; CAD 110,000 - 125,000; Full time

Job summary

Kelly Services is recruiting an experienced Quality Assurance & Regulatory Affairs (QA/RA) Manager for a medical device manufacturer in Markham, Ontario.

You will lead Quality Engineering, Quality Systems, Regulatory Affairs and Quality Control, ensuring ISO 13485, MDSAP compliance and Health Canada licensing.

This is a 100% on-site role with opportunities to drive continuous improvement and regulatory success across the site.

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.
• 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.
• Ability to work 100% on-site in Markham, Ontario.

Responsibilities

• 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.

Skills

Quality leadership

ISO 13485

MDSAP

Health Canada Regulations

Audits

CAPA

Regulatory Affairs

Education

Bachelor's degree in Engineering, Science, or related field

Job description

WE'RE HIRING! QUALITY ASSURANCE & REGULATORY AFFAIRS MANAGER

Employment Type: Full-Time, Permanent

Industry: Medical Devices

Salary: $110,000–$125,000 CAD annually

ABOUT THE OPPORTUNITY

Kelly Services is recruiting an experienced Quality Assurance & Regulatory Affairs (QA/RA) Manager on behalf of one of our clients, an established medical device manufacturer located in Markham, Ontario.

This is an exciting opportunity for an experienced quality leader to oversee Quality Engineering, Quality Systems, Regulatory Affairs, and Quality Control while driving regulatory compliance, operational excellence, and continuous improvement.

Reporting to the Senior Director, Global Quality Operations, you will lead the Quality team, oversee the effectiveness of the Quality Management System (QMS), and serve as the site's ISO 13485 Management Representative and primary Health Canada regulatory contact.

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.
• 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

• 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.