Position Overview
The Quality intern supports product development, manufacturing, quality assurance, and regulatory compliance activities for medical devices. This role is responsible for managing design changes, maintaining technical and quality documentation, supporting supplier and manufacturing quality, ensuring compliance with ISO 13485 and regulatory requirements, and contributing to continuous improvement initiatives.
Key Responsibilities
- Implement design changes, DFM activities, and product improvements.
- Create, update, and maintain inspection and manufacturing documentation.
- Manage non-conforming products, supplier rework activities, and corrective actions.
- Support process validation, equipment maintenance, and manufacturing quality activities.
- Maintain technical and regulatory documentation, including DHF, DMR, and MDR files.
- Support the Quality Management System (QMS) and ensure compliance with ISO 13485 and applicable regulations.
- Assist with complaint handling, investigations, CAPA, and non-conformance evaluations.
- Prepare regulatory submissions and responses to international regulatory authorities.
- Support internal and external audits and provide required documentation.
- Participate in continuous improvement projects and process enhancement initiatives.
- Coordinate prototype manufacturing activities and supplier follow-up.
- Assist with product release documentation and market launch approvals.
Required Qualifications
- · Mechanical or Biomechanical Engineers
- · Detail-oriented and strong organizational, problem solving and analytical skills
- · Proficient in Microsoft Office Software
- · Must be proficient in spoken/written English
- · Must be eligible to work in Canada at time of application
- · Must be enrolled as a full-time student in a Canadian University
- · Knowledge of machining & manufacturing processes
- Preferred Qualifications
- · Knowledge of inspection equipment
- · Regulatory or Quality System experience preferred
- · Knowledge in 3D modeling and 2D drawings - SolidWorks experience preferred
