Quality Engineer

• Assist with the development and implementation of a robust and compliant quality management system (QMS) aligned with industry standards including ISO 13485:2016 and the Canadian Medical Devices Regulations (CMDR).
• Support the maintenance and updating of quality procedures, and documentation as required.
• Assist with conducting internal audits to identify areas for improvement and ensure compliance.

• Actively participating in cross-functional product development teams, ensuring quality is integrated into design and manufacturing processes from concept to design transfer and launch.
• Reviewing design documents, specifications, and risk assessments to identify potential quality issues.
• Supporting the development and execution of process validation and verification protocols and procedures.

• Support Purchasing with the evaluation and approval of suppliers for raw materials and services to ensure they meet quality and company requirements.
• Managing supplier quality issues and implementing corrective actions.

• Investigating non-conforming materials and products, identifying root causes, and implementing corrective and preventive actions, as appropriate, following the CAPA procedure to prevent recurrence.
• Managing the non-conformance reporting system and ensuring timely resolution of issues.
• Manage customer complaints including trending and follow-up actions as required.

• Analyzing quality data to identify trends and implement continuous improvement initiatives.
• Assist with employee training activities to support site training plan.

• Minimum 3 years' experience in medical device quality management systems, or relevant fields
• Bachelor's degree in Engineering or related field

• Solid knowledge of ISO 13485, FDA regulations, and other applicable quality and regulatory standards within medical device or PPE manufacturing environments
• Proficiency in quality analysis and problem-solving methodologies (e.g., root cause analysis, CAPA, continuous improvement tools) to drive product and process improvements
• Strong communication and interpersonal skills, with the ability to effectively collaborate across cross-functional teams (Operations, Engineering, Quality, Supply Chain)
• Demonstrated experience leading quality initiatives, with a focus on continuous improvement and operational excellence
• Excellent organizational and prioritization skills, with the ability to manage multiple stakeholders and project timelines effectively
• Ability to thrive in a fast-paced, project-based environment, demonstrating adaptability and resilience under pressure
• High level of attention to detail, rigor, and accuracy in all aspects of quality management
• Self-driven with a strong sense of ownership, autonomy, and proactive problem-solving, including the ability to propose and implement improvements

• Comprehensive insurance program including EAP and telemedicine for you and your family.
• 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.

• Work is performed in a combination of office and manufacturing environments
• The role requires regular on-site presence in production areas and extended periods of computer and screen use
• Standard work schedule is daytime hours; however, occasional attendance outside regular hours (including early, late, or shift-based hours) may be required to support commissioning, operational needs, or improvement activities
• Occasional travel may be required based on business needs

Medicom