Medical Device Quality Engineer - ISO & CAPA Expert (6mo)

SRG; Lancashire; On-site; GBP 42,000 - 54,000; Full time

Job summary

SRG is seeking an experienced Quality Engineer to join a growing medical device business on an initial 6 month contract. You will help maintain and improve QMS in line with ISO 13485 and regulatory requirements, supporting product development and manufacturing worldwide.

Joining a cross‑functional team, you will drive CAPA investigations, root cause analysis, risk management, and continuous improvement across manufacturing and supply chain to ensure compliant, high‑quality medical technologies.

Qualifications

• Degree in Engineering, Science, Quality, or a related discipline.
• Experience in Quality Engineering or Quality Assurance in a regulated environment.
• Knowledge of ISO 13485 and medical device quality requirements.
• Experience managing CAPAs, non-conformances and root cause investigations.
• Understanding of risk management and validation activities.
• Excellent communication and stakeholder management skills.
• Strong analytical and problem-solving abilities.

Responsibilities

• Support and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and applicable regulations.
• Lead investigations into non-conformances, deviations, complaints, and CAPAs.
• Conduct root cause analysis and implement corrective and preventive actions.
• Support internal, supplier, and external audits, including regulatory inspections.
• Review and approve quality documentation, including procedures, work instructions, and validation reports.
• Drive continuous improvement initiatives across manufacturing and operational processes.
• Support risk management activities in line with ISO 14971.
• Monitor quality metrics and identify opportunities for improvement.
• Work closely with suppliers to ensure material and component quality standards are maintained.
• Participate in design transfer, validation, and product lifecycle quality activities.

Skills

Quality engineering

CAPA management

Root cause analysis

Regulatory compliance

ISO 13485 knowledge

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related discipline

Job description

SRG is seeking an experienced Quality Engineer to join a growing medical device business on an initial 6 month contract. You will help maintain and improve QMS in line with ISO 13485 and regulatory requirements, supporting product development and manufacturing worldwide.

Joining a cross‑functional team, you will drive CAPA investigations, root cause analysis, risk management, and continuous improvement across manufacturing and supply chain to ensure compliant, high‑quality medical technologies.