Quality System Specialist

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

Job summary

A leading medical device company in London, Ontario is seeking a Quality System Specialist to ensure the Quality Management System remains compliant with ISO 13485 and relevant Canadian regulations. The specialist will be responsible for maintaining documentation, conducting audits, and providing training related to quality systems. Competitive salary and comprehensive benefits package offered.

Benefits

Competitive salary

Comprehensive benefits package, including Employee Assistance Program

Company-matched retirement plan

Opportunities for training and professional development

Dynamic and friendly work environment with social activities

Qualifications

• Minimum 3 years of experience with ISO 13485 and MDSAP compliance.
• Certified Internal Auditor.
• Experience conducting internal QMS audits.
• Ability to deliver training on ISO 13485 requirements.

Responsibilities

• Maintain the QMS to ensure compliance with ISO 13485, MDSAP, and MDL requirements.
• Manage all QMS documentation, including Medical Device Files, Change Requests, and Risk Management Files.
• Ensure timely processing of QMS changes in the eQMS.
• Provide training to employees on QMS documentation and eQMS tools.
• Liaise with ISO Certification Body to coordinate audits and regulatory inspections.
• Conduct internal audits and support audit readiness activities.
• Stay up to date on relevant quality and regulatory standards for medical devices.
• Support continuous improvement initiatives within the QMS framework.

Skills

Strong understanding of ISO 13485 Quality Management System requirements

Knowledge of Canadian medical device regulatory requirements

Experience with document control systems, especially eQMS

Proficiency in managing QMS documentation and records

Education

University or college degree in a science, technical, or regulatory field

Job description

About Medicom

Think you have what it takes to work in an organization where creativity, drive and ambition are valued while integrity motivates everything we do?

Medicom has been in business for over 35 years, and it has kept its entrepreneurial mindset. Working with us, you will have the opportunity to get involved, have an impact, and contribute to the company’s continued growth. We live by our values every day, focussing on customer satisfaction while ensuring teamwork, accountability, and empathy in everything we do.

Our team loves challenges and a fast-paced environment. You will have the flexibility to manage work and a personal life, as well as your own personal well-being.

The Opportunity

We are looking for a Quality System Specialist to ensure the company’s Quality Management System (QMS) remains compliant with ISO 13485 and relevant Canadian medical device regulatory requirements. You will be responsible for maintaining documentation in the eQMS, conducting audits, and supporting internal training related to quality systems.

Key Responsibilities

• Maintain the QMS to ensure compliance with ISO 13485, MDSAP, and Medical Device License (MDL) requirements.
• Manage all QMS documentation, including Medical Device Files, Change Requests, Risk Management Files, and Design Files.
• Ensure timely processing of QMS changes in the eQMS.
• Provide training to employees on QMS documentation and eQMS tools.
• Liaise with ISO Certification Body to coordinate audits and regulatory inspections.
• Conduct internal audits and support audit readiness activities.
• Stay up to date on relevant quality and regulatory standards for medical devices.
• Support continuous improvement initiatives within the QMS framework.
• Other duties as assigned by the Manager, Quality Operations.

What You Bring

University or college degree in a science, technical, or regulatory field.

Strong understanding of ISO 13485 Quality Management System requirements.

Knowledge of Canadian medical device regulatory requirements.

Experience with document control systems, especially eQMS.

Proficiency in managing QMS documentation and records.

Assets :

Minimum 3 years of experience with ISO 13485 and MDSAP compliance.

Certified Internal Auditor.

Experience conducting internal QMS audits.

Ability to deliver training on ISO 13485 requirements.

What We Offer

Competitive salary.

Comprehensive benefits package, including Employee Assistance Program (EAP) and telemedicine services.

Company-matched retirement plan.

Opportunities for training, coaching, and professional development.

A dynamic and friendly work environment, with an active social committee organizing events such as sports activities, BBQs, and family gatherings.

Equal Opportunity Employer

Medicom is an equal opportunity employer. We consider all applicants without regard to age, gender, gender identity or expression, sexual orientation, race, ethnic or national origin, religious beliefs, sex (including pregnancy and breastfeeding), disability or marital or family status. We welcome applications from all qualified individuals and encourage Indigenous persons, persons of color, LGBTQ+ and gender-nonconforming persons, persons with disabilities, women, and members of any other marginalized group.

If you are energetic, committed to making a difference and love challenges, we would love to hear from you.

Visit our website at medicom.com / en_ca / careers and apply today!