Risk-based validation expertise drives this Quality Engineer role at STEMCELL Technologies, supporting cGMP processes, analytical methods, and equipment lifecycle verification.
Based in Vancouver with STEMCELL Technologies, this Quality Engineer supports project execution across commissioning, qualification, validation, and hand-over activities. The work spans Manufacturing, Quality Control, Process Development, and Instrumentation. You will develop project documentation, support quality assurance compliance, and contribute to continuous improvement.
Key Responsibilities:
- Develop metrics for process effectiveness and improvement progress
- Participate in Process Performance Qualification conformance lot manufacturing
- Perform non-conformance and CAPA investigations when needed
- Prepare, review,
and coordinate validation documentation
- Educate employees on applicable quality standards
Requirements:
- Bachelor’s degree in Biomedical Engineering or equivalent
- Two to six years of validation experience
- Familiarity with risk management, ISO 14971, and cGMP
- Experience qualifying utilities, facilities, equipment, and software
- Robust technical writing, analysis, project, and time management skills
Apply risk-based validation, technical documentation, and quality assurance expertise to support STEMCELL Technologies’ life science research products.