Senior Quality Engineer

Job Description Summary STEMCELL Technologies, Canada’s largest biotech company is looking for a Senior Quality Engineer to join our team out of our Cambridge, Waterbeach site! As the Senior Quality Engineer, you will support the development and manufacture of innovative instrumentation and single-use consumables for GMP cell and gene therapy manufacturing, as well as research use only (RUO) applications. Working closely with Engineering, Manufacturing, and the broader Quality team, you will provide quality expertise throughout the product lifecycle, ensuring products meet applicable regulatory and quality requirements. Job Description Duties and Responsibilities Lead Design Control and risk management activities, including Hazard Analysis and Design and Process FMEA, to identify and control risks and ensure compliance with ISO 13485, 21 CFR Part 820, cGMP, ISO 14971, IEC 60601-1, IEC 61010-1, RoHS and WEEE and other applicable requirements Evaluate and approve technical documentation, Design input documents, verification and validation reports, vendor qualification and design transfer activities and overall independent quality support for the project Develop and implement risk-based inspection plans and in-process and final inspection procedures, including appropriate sampling strategies for instrumentation components Performs quality inspection/processing of incoming raw materials and final inspection testing Builds and maintains quality metrics and supports all QMS activities such as document management, non conformance investigations (NCRs/SCARs), CCRs, CAPAs, internal and external audits and factory inspections Knowledge and Qualifications Bachelor’s degree in Mechanical, Electrical, Software, or Biomedical Engineering with 6–10 years of relevant experience, or a Master’s degree with 4+ years of experience; an advanced degree is preferred Experience in an instrumentation or manufacturing environment is preferred Strong systems knowledge, including experience with Enterprise Resource Planning, Product Life Cycle Management, and Requirements Management Systems, is considered an asset  Strong knowledge across mechanical, electrical, and software engineering disciplines, with extensive understanding of applicable regulatory and quality standards Demonstrated ability to review complex designs, develop risk management documentation, and establish processes that support manufacturing in alignment with design specifications #LI-KK1 #LI-Onsite #Bench STEMCELL Technologies is a privately owned, Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality, we are a company of Scientists Helping Scientists—standing by our customers to provide the outstanding products, technical support, and training they need to advance their research. Scientists performing stem cell, immunology, cancer, regenerative…