Senior Quality Engineer – GMP Instrumentation (Biotech)

STEMCELL Technologies; Cambridge; On-site; GBP 46,000 - 69,000; Full time

Benefits offered by this job

Health benefits

Career development

Retirement savings

Job summary

STEMCELL Technologies, a Vancouver-based biotech leader, is seeking a Senior Quality Engineer to support GMP cell and gene therapy instrumentation manufacturing at the Cambridge Waterbeach site. You will work with Engineering, Manufacturing, and Quality to ensure regulatory compliance and high-quality product realization.

The role requires 6–10 years in engineering and strong experience in design controls, risk management, and quality systems.

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 instrumentation or manufacturing environments is preferred.
• Strong systems knowledge across ERP, PLM, and requirements management systems.
• Broad knowledge of regulatory and quality standards in medical device manufacturing.

Responsibilities

• Lead Design Control and risk management activities including Hazard Analysis and Design and Process FMEA.
• Approve technical documentation, design inputs, verification/validation, and vendor qualifications.
• Develop risk-based inspection plans and sampling strategies for instrumentation components.
• Perform quality inspection/processing of incoming materials and final testing.
• Maintain quality metrics and support QMS activities (NCRs/SCARs, CAPAs, audits).

Skills

Mechanical engineering

Electrical engineering

Software engineering

Biomedical engineering

Regulatory knowledge

Education

Bachelor’s degree in Mechanical, Electrical, Software, or Biomedical Engineering

Master’s degree (preferred)

Tools

ERP

PLM

Requirements Management

Job description

STEMCELL Technologies, a Vancouver-based biotech leader, is seeking a Senior Quality Engineer to support GMP cell and gene therapy instrumentation manufacturing at the Cambridge Waterbeach site. You will work with Engineering, Manufacturing, and Quality to ensure regulatory compliance and high-quality product realization.

The role requires 6–10 years in engineering and strong experience in design controls, risk management, and quality systems.