Quality Engineer

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 Engineer to join our Quality Operations team at our new nitrile glove manufacturing facility in London, Ontario. The Quality Engineer will be a key contributor to our Quality Management System (QMS), working closely with cross-functional teams to ensure product compliance, continuous improvement, and audit readiness in line with ISO 13485 and applicable regulatory standards.

What You Will Do
 

• Collaborate with Engineering and Manufacturing to ensure quality standards are implemented and maintained
• Provide training on QMS procedures and eQMS tools to production and quality staff
• Conduct internal audits and support external audit readiness
• Manage QMS documentation, including Medical Device Files, Change Requests, Risk Management Files, and Design History Files
• Investigate Non-Conformances (NCRs) and implement effective dispositions
• Support and participate in continuous improvement initiatives Perform validation activities (IQ, OQ, PQ)
• Carry out other duties assigned by the Manager, Quality Operations
   

• Minimum 3 years of experience in Quality or a related field Experience with validation activities (IQ, OQ, PQ)
• Hands-on experience with Root Cause Analysis & CAPA
• Experience with document control systems, particularly eQMS
• Experience managing Non-Conformances (NCRs)
• Strong written and verbal communication skills
• Experience training staff on procedures
• University or college degree in a science, technical, or regulatory field
   

• Experience in the Medical Device industry Strong understanding of ISO 13485
• Knowledge of Canadian medical device regulatory requirements
• Experience with MES systems
• Experience conducting internal QMS audits
• Six Sigma training
• ASQ CQE certification
   

• 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.