24 Sep
|
Socket.dev
|
Kitchener
24 Sep
Socket.dev
Kitchener
ME Quality Assurance Co-op
Kitchener, Ontario | Primarily Onsite with Possible Remote Days
Join Sonova's Quality and Regulatory Affairs team as an ME Quality Assurance Co-op and gain hands-on experience supporting quality activities in a medical-device manufacturing workplace.
Working with the Manufacturing Engineering Quality Assurance team, you will help maintain quality documentation, support non-conformance and corrective action processes, analyze quality data and contribute to continuous improvement projects.
Responsibilities
- Support the review, approval routing, formatting and revision control of quality system documents.
- Maintain records in the electronic Quality Management System (eQMS) and help ensure documentation follows internal procedures and Good Documentation Practices.
- Support updates to Manufacturing Engineering quality documentation and the ME QA Confluence workspace.
- Assist with the initiation, tracking and documentation of non-conformances.
- Collect data for root cause investigations and support corrective and preventive action (CAPA) tracking, records and effectiveness checks.
- Help compile quality metrics, identify trends and support continuous improvement initiatives.
- Assist with quality activities related to Manufacturing Engineering projects,
including design transfer.
- Collaborate with Manufacturing Engineering, Operations, Quality and Regulatory Affairs teams, and communicate project updates.
More About You
- Currently and actively enrolled in a recognized Ontario college or university program throughout the co-op placement. This is a required qualification; applicants who have already graduated are not eligible.
- Studying Quality Assurance, Regulatory Affairs, Biomedical Engineering, Engineering Technology, Life Sciences, Manufacturing Engineering or a related technical discipline.
- Organized, detail-oriented and able to manage multiple tasks reliably.
- Strong written and verbal communication skills in English.
- Comfortable working independently and collaborating with cross-functional teams.
- Proficient with Microsoft Office applications.
- Knowledge of ISO 13485 or ISO 9001 is an asset.
- Exposure to eQMS, design transfer, process validation, non-conformances or CAPA is an asset.
Work Arrangement
This position is based in Kitchener, Ontario and will work primarily onsite , with possible remote days depending on business needs, assigned responsibilities and manager approval.
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📌 Manufacturing Engineering QA Co-op (Kitchener)
🏢 Socket.dev
📍 Kitchener