Manufacturing Engineering QA Co-op

Job summary

The co-op will support quality documentation, non-conformance processes, and corrective action tracking within a medical-device manufacturing environment. They will also assist in compiling quality metrics and collaborating with cross-functional teams on manufacturing engineering projects.

Job details

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.

What you’ll do

The co-op will support quality documentation, non-conformance processes, and corrective action tracking within a medical-device manufacturing environment. They will also assist in compiling quality metrics and collaborating with cross-functional teams on manufacturing engineering projects.

Requirements

Applicants must be currently enrolled in a recognized Ontario college or university program in a technical discipline such as Engineering or Life Sciences. Strong communication skills and proficiency with Microsoft Office are required, while knowledge of ISO standards or eQMS is considered an asset.

Listed skills

• Continuous Improvement · Preferred
• Quality assurance · Preferred
• Root Cause Analysis · Preferred
• Microsoft Office · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality Assurance
• Regulatory Affairs
• Manufacturing Engineering
• Documentation Control
• Non-conformance Management
• CAPA
• Root Cause Analysis
• Quality Metrics
• Continuous Improvement
• Design Transfer
• Microsoft Office
• ISO 13485
• ISO 9001
• eQMS
• Process Validation
• Operations
• English Language
• ISO 9000 Series
• Continuous Improvement Process
• Detail Oriented
• Safety Assurance
• Atlassian Confluence
• Investigation
• Verbal Communication Skills
• Life Sciences
• Version Control
• Data Collection
• Network Routing
• Quality Management Systems
• Corrective And Preventive Action (CAPA)
• Biomedical Engineering
• ISO 13485 Standard
• Good Documentation Practices
• Medical Device Manufacturing

Job areas

• Engineering
• Manufacturing
• Healthcare
• Science & Research
• Manufacturing Engineering Manager
• Manufacturing Engineer (General)
• Industrial and Production Engineers
• Manufacturing Engineers
• Industrial Engineers

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