Quality Intern
- Laval, QC, Canada
Full-time
Applications open in a new tab.
Job details
- Job type
- Full-time
- Apply by
- Posting language
- English
- Posted
Original job description
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
More about this job
Responsibilities
Support medical device product development, manufacturing quality, and regulatory compliance by managing design changes, maintaining technical and quality records, and assisting with supplier and manufacturing activities. Contribute to complaint investigations, CAPA, audits, regulatory submissions, product releases, and continuous improvement initiatives.
Requirements
Applicants must be mechanical or biomechanical engineering students enrolled full-time at a Canadian university and eligible to work in Canada. They should have strong organizational, analytical, and problem-solving skills, proficiency in Microsoft Office and English, and knowledge of machining and manufacturing; inspection equipment, quality systems, regulatory experience, and SolidWorks are preferred.
Skills
- Design Change Management
- Design for Manufacturing
- Manufacturing Documentation
- Inspection Documentation
- Non-Conformance Management
- Supplier Quality
- Corrective Actions
- Process Validation
- Quality Management Systems
- ISO 13485 Compliance
- Regulatory Documentation
- Complaint Handling
- CAPA
- Audit Support
- Continuous Improvement
- SolidWorks
Visa sponsorship
Not detected in the job text
Categories
- Engineering
- Manufacturing
- Healthcare
- Security & Safety
Keywords
- Medical Devices
- ISO 13485
- Quality Management System
- Design History File
- Device Master Record
- Medical Device Reporting
- Design Changes
- Design for Manufacturing
- Product Improvement
- Manufacturing Processes
- Machining
- Inspection Equipment
- Supplier Quality
- Non-Conforming Products
- Corrective Actions
- Process Validation
- Equipment Maintenance
- Regulatory Compliance
- Regulatory Submissions
- Complaint Handling
- Investigations
- CAPA
- Audits
- Continuous Improvement
- Prototype Manufacturing
- Product Release
- Microsoft Office
- SolidWorks
- 3D Modeling
- 2D Drawings