Quality System Specialist

CameleonHR; London; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading company in the regulated manufacturing sector seeks a Quality System Specialist to ensure compliance with ISO 13485 and improve document management. You will manage eQMS documentation, provide training, and prepare for audits, making a significant impact in a standards-driven environment. This role offers the opportunity for professional growth and to contribute to regulatory excellence.

Benefits

Competitive salary

Professional growth opportunities

Qualifications

• Degree in science, technical, or regulatory field required.
• Strong knowledge of ISO 13485 and Canadian medical device regulations.
• Experience managing QMS documentation in a regulated environment.

Responsibilities

• Maintain the QMS in alignment with ISO 13485 and Health Canada regulations.
• Update and control QMS documentation in the eQMS system.
• Support audit preparation and liaise with ISO Certification Bodies.

Skills

ISO 13485

Document Control

Regulatory Compliance

Education

University or college degree in science, technical or regulatory field

Tools

eQMS

Job description

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