Quality Engineer Process Qualification
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Process qualification and continuous improvement shape this Quality Engineer opportunity with Vancouver-based STEMCELL Technologies in life science research.
The role focuses on validation, commissioning, and qualification documentation supporting regulated processes, analytical methods, and equipment. You will report process metrics, track improvement opportunities, and support performance objectives. Collaboration extends across Manufacturing, Quality Control, Process Development, and Instrumentation departments.
Key Responsibilities:
- Report metrics on process effectiveness and improvement opportunities
- Support validation, commissioning, and qualification document execution
- Participate in PPQ conformance lot manufacturing
- Investigate non-conformances and CAPAs as needed
- Coach employees toward applicable quality standards
Requirements:
- Biomedical Engineering degree or equivalent education
- Two to six years of validation experience
- Experience with utilities, facilities, and equipment qualification
- Familiarity with software assurance and Continued Monitoring concepts
- Strong project and time management skills
Use process qualification, metrics development, and continuous improvement knowledge to strengthen quality activities at STEMCELL Technologies.