Location: London, Ontario
Job Type: Permanent – Full Time - On site
Work Environment
You will be part of a regulated and ISO 13485-certified manufacturing environment where quality, precision, and continuous improvement are central. The team values documentation integrity, proactive compliance, and collaborative audit readiness.
Your Role
As the Quality System Specialist, you will ensure the company's Quality Management System (QMS) remains compliant with ISO 13485 and Canadian regulatory requirements. You will manage eQMS documentation, support audits, and lead training initiatives.
Key Responsibilities
Maintain the QMS in alignment with ISO 13485, MDSAP, and Health Canada regulations
Update and control QMS documentation in the eQMS system
Ensure all changes are implemented and documented in a timely manner
Provide employee training on eQMS systems and procedures
Manage files such as Medical Device Files, Risk Management Files, Design Files, and Change Requests
Support audit preparation and liaise with ISO Certification Bodies
Monitor compliance and propose improvements where needed
What You Bring
Required:
University or college degree in science, technical or regulatory field
Strong knowledge of ISO 13485 and Canadian medical device regulations
Proficiency in document control systems, especially eQMS
Experience managing QMS documentation in a regulated environment
Assets:
Minimum 3 years of experience with ISO 13485 and MDSAP
Internal Auditor certification
Experience conducting internal QMS audits
Experience delivering ISO 13485 training
Why Apply
Join a purpose-driven manufacturing team with a commitment to compliance and safety
Competitive salary and professional growth opportunities
Be a core contributor to audit success and regulatory excellence
