Manufacturing Engineering QA Co-op

Sonova Group; Kitchener; Hybrid; CAD 25,000 - 30,000; Part time

Job summary

Sonova Group in Kitchener, Ontario, is seeking a hands-on ME Quality Assurance Co-op to support quality activities in a medical-device manufacturing environment. You will help maintain quality documentation, analyze data and support CAPA tracking while collaborating with cross-functional teams.

This co-op requires enrollment in an Ontario college/university program and studying in QA, regulatory affairs, or related fields.

Qualifications

• Must be currently enrolled in an Ontario college or university program for the duration of the co-op placement.
• Studies in Quality Assurance, Regulatory Affairs, Biomedical Engineering, Engineering Technology, Life Sciences, Manufacturing Engineering or related technical discipline.
• Organized, detail-oriented and able to multitask reliably.
• Strong written and verbal communication skills in English.
• Proficient with Microsoft Office applications.

Responsibilities

• Support review, approval routing, formatting and revision control of quality system documents.
• Maintain records in the electronic Quality Management System (eQMS) and ensure documentation follows internal procedures and Good Documentation Practices.
• Assist with updates to ME QA documentation and the Confluence workspace.
• Assist with initiation, tracking and documentation of non-conformances.
• Collect data for root cause investigations and support CAPA tracking 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, communicating project updates.

Skills

Detail oriented

Organised

Multitasking

English communication

MS Office proficient

Education

Ontario college/university program (co-op)

Tools

eQMS

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.


• Organised, 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.

Sonova is an equal opportunity employer. We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.