At a Glance
- Tasks: Lead and develop a Quality team in medical device manufacturing.
- Company: Established medical device manufacturer in Markham, Ontario.
- Benefits: Competitive salary, career growth, and impactful work in healthcare.
- Other info: 100% on-site with a mix of office and manufacturing responsibilities.
- Why this job: Make a difference in product safety and regulatory compliance.
- Qualifications: 7+ years in Quality Assurance/Regulatory Affairs and strong leadership skills.
The predicted salary is between 110000 - 125000 $ per year.
WE'RE HIRING! QUALITY ASSURANCE & REGULATORY AFFAIRS MANAGER
Employment Type
Full-Time, Permanent
Industry
Medical Devices
Salary
- 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.
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Quality Assurance / Regulatory Affairs Manager in Markham employer: Kelly
As a leading Consumer Health organization, we pride ourselves on fostering a dynamic work environment that encourages creativity and collaboration. Our commitment to employee growth is evident through ongoing professional development opportunities and a supportive culture that values diverse perspectives. Located in a vibrant community, we offer competitive benefits and the chance to make a meaningful impact on brand reputation management during this exciting contract role.
