Manufacturing Engineering QA Co-op

Socket.dev; Kitchener; On-site; CAD 25,000 - 32,000; Full time

Benefits offered by this job

Possible remote days

Onsite in Kitchener, Ontario

Job summary

Sonova's Manufacturing Engineering Quality Assurance team in Kitchener, Ontario, is seeking an ME Quality Assurance Co-op to gain hands-on experience supporting quality activities in a medical-device manufacturing environment. This onsite role offers exposure to document control, CAPA, non-conformances, and data analysis.

You will work with cross-functional teams, maintain eQMS records, assist with design transfer and project updates, and contribute to continuous improvement initiatives while

Qualifications

• Must be actively enrolled in an Ontario college or university program throughout the co-op placement.
• Studying Quality Assurance, Regulatory Affairs, Biomedical Engineering, Engineering Technology, Life Sciences or 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.

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.

Skills

Communication skills

Organized

Independent worker

Team collaboration

Education

Enrollment in Ontario college/university program

Tools

MS Office

eQMS exposure

ISO 13485 knowledge

CAPA exposure

Job description

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 environment.

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.