Quality Engineer

About the job

About Medicom

Founded in 1988, Medicom is a global leader in the manufacturing and distribution of infection control solutions. We take pride in providing essential products to healthcare professionals, laboratories, governments, and critical industries in over 95 countries. Our mission is to protect people by delivering high-quality, innovative solutions.

Why Join Medicom?

By joining our team, you will become part of a dynamic and growing company committed to making a real difference in the healthcare industry. We value innovation, collaboration, and professional development.

Position Overview

As a Quality Engineer, you will play a crucial role in ensuring compliance with quality and regulatory requirements throughout the product lifecycle. You will lead and support cross-functional teams, manage internal audits, and maintain quality documentation in alignment with industry standards and regulations.

Key Responsibilities

Quality System Management

• Assist in developing and implementing a robust and compliant Quality Management System (QMS) aligned with ISO 13485:2016 and the Canadian Medical Devices Regulations (CMDR).
• Maintain and update quality procedures and documentation.
• Conduct internal audits to ensure compliance and identify areas for improvement.

• Support Collaborate with cross-functional teams to integrate quality standards into product design and manufacturing processes.
• Review design documents, specifications, and risk assessments to identify potential quality issues.
• Lead validation and verification protocols.
   

• Support purchasing teams in evaluating and approving suppliers to ensure they meet quality requirements.
• Manage supplier quality issues and implement corrective actions.
• Non-Conformance & Corrective/Preventive Actions Investigate non-conforming materials and products, identifying root causes and implementing corrective actions.
• Manage non-conformance reporting and ensure timely resolution.
• Handle customer complaints, including trend analysis and follow-ups.

• Analyze quality data to identify trends and drive continuous improvement.
• Assist with employee training initiatives to support site-wide quality training plans.

• Bachelor's degree in Engineering or a related field .
• Minimum 5 years of experience in medical device quality management systems or related industries.
• Strong knowledge of ISO 13485, FDA regulations, and other relevant industry standards.
• Experience using quality analysis tools for problem-solving and quality improvements.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively across departments and lead quality initiatives.
• Strong organizational, analytical, and problem-solving skills.
   

• Knowledge of ISO 9001 standards and associated regulations.
• Experience with supplier quality management and auditing.
   

• 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.