Senior Quality Engineer – Instrumentation & GMP

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

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