Risk-based validation and cGMP expertise define this Quality Engineer opportunity with STEMCELL Technologies in Vancouver, supporting lifecycle verification activities.
As a Quality Engineer, you will support processes, analytical methods, and equipment lifecycle verification. The work spans commissioning, qualification, validation, and project hand-over across Manufacturing, Quality Control, Process Development, and Instrumentation. You will develop project documentation and support quality assurance compliance activities.
Key Responsibilities:
- Develop metrics for process effectiveness and improvement progress
- Participate in PPQ conformance lot manufacturing and investigations
- Prepare and coordinate validation, commissioning, and qualification documentation
- Establish procedures supporting applicable regulatory compliance
- Educate and coach employees on quality standards
Requirements:
- Bachelor’s degree in Biomedical Engineering or equivalent
- Two to six years’ 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 management, validation, and quality systems expertise to support STEMCELL Technologies’ life science research products.