Senior Quality Engineer – GMP Instrumentation

STEMCELL Technologies Inc; United Kingdom; Remote; GBP 46,000 - 69,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Career development

Job summary

STEMCELL Technologies Inc., Cambridge-based, seeks a Senior Quality Engineer to support GMP cell and gene therapy product lifecycle from development through manufacturing. You will lead design control, risk management, and QA activities, aligning documentation, tests, and audits with ISO and CFR standards.

The role emphasizes cross-functional collaboration with Engineering and Manufacturing, ensuring robust quality systems, CAPAs, and supplier qualification.

Qualifications

• Bachelor’s in engineering with 6–10 years of relevant experience, or Master’s with 4+ years.
• Experience in instrumentation/manufacturing environments preferred.
• Strong systems knowledge and regulatory quality standards.
• Ability to review complex designs and establish compliant processes.

Responsibilities

• Lead Design Control and risk management activities to ensure compliance.
• Evaluate technical docs, verifications, validations, and design transfers.
• Develop risk-based inspection plans and sampling strategies.
• Perform incoming material QA and final inspection testing.
• Maintain quality metrics and support NCRs/SCARs, CAPAs, audits.

Skills

Quality assurance

Design control

Risk management

Regulatory knowledge

GMP compliance

Education

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

Master’s degree with 4+ years of experience

Tools

ERP

Product Life Cycle Management

Requirements Management Systems

Job description

STEMCELL Technologies Inc., Cambridge-based, seeks a Senior Quality Engineer to support GMP cell and gene therapy product lifecycle from development through manufacturing. You will lead design control, risk management, and QA activities, aligning documentation, tests, and audits with ISO and CFR standards.

The role emphasizes cross-functional collaboration with Engineering and Manufacturing, ensuring robust quality systems, CAPAs, and supplier qualification.