Quality System Specialist

2 weeks ago

London, Canada Medicom Full time

**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**

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

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