Senior Quality Engineer

STU STEMCELL Technologies UK Ltd.; Cambridge, Waterbeach; On-site; GBP 46,000 - 69,000; Full time

Job summary

STEMCELL Technologies, a Canada-based biotech leader, seeks a Senior Quality Engineer for its Cambridge Waterbeach site. You will drive ISO 13485, 21 CFR Part 820 compliance across design, process, and manufacturing of GMP instruments and single-use consumables for cell/gene therapy, collaborating with Engineering, Manufacturing, and Quality teams.

You will review technical docs, enable design transfers, and implement risk-based inspection programs, while supporting QMS, audits, NCRs/SCARs, and

Qualifications

• Bachelors in Mechanical, Electrical, Software or Biomedical Engineering with 6–10 years’ experience, or a Master’s with 4+ years.
• Experience in instrumentation/manufacturing environments is preferred.
• Strong systems knowledge with ERP/PLM/RM experience is a plus.

Responsibilities

• Lead design control and risk management activities per ISO 13485, 21 CFR Part 820, and related standards.
• Evaluate and approve technical documents, verifications, validations, and design transfers.
• Develop risk-based inspection plans and sampling strategies for instrumentation components.
• Perform quality inspection of incoming materials and final testing.
• Maintain quality metrics and support QMS, NCRs/SCARs, audits, and CAPAs.

Skills

Quality engineering

Regulatory knowledge

Design controls

Education

Bachelor’s/Master’s in engineering

Tools

ERP systems

PLM

RM systems

Job description

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

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About STEMCELL Technologies

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 medicine, and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, accessory products, and services. Through our many regional offices, as well as our distribution centers in Vancouver, Seattle, Grenoble, and Singapore, we deliver our innovative, specialized products to more than 100 countries. With over 1,800 employees globally, most with scientific or engineering degrees, STEMCELL is proud to be the largest biotechnology employer in Canada. This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities. STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.

Equal Opportunity Employment

As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.

Compensation and Benefits

The annual salary for this job ranges from: £46,100.00 - £69,100.00 STEMCELL determines an individual’s pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package that may include health benefits, retirement savings, and more (depending on region).