Impactful Medical Device Quality Engineer | ISO 13485, CAPA

Energy Jobline CVL; Lancashire; On-site; GBP 46,000 - 77,000; Full time

Job summary

Energy Jobline CVL is seeking an experienced Quality Engineer to join a growing medical device business on an initial 6 month contract. You will support the Quality Management System and help ensure compliance with regulatory requirements.

Working closely with Manufacturing, R&D, Regulatory Affairs, and Supply Chain, you will lead investigations into non-conformances, CAPAs, risk assessments, and validation activities to safeguard product quality.

Qualifications

• Degree in Engineering, Science, Quality or related discipline.
• Experience in Quality Engineering/Quality Assurance in medical device, pharmaceutical, or highly regulated industry.
• Knowledge of ISO 13485 and medical device quality requirements.
• Experience managing CAPAs, non-conformances, and root-cause investigations.
• Knowledge 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, 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.

Education

Degree in Engineering, Science, Quality

Job description

Energy Jobline CVL is seeking an experienced Quality Engineer to join a growing medical device business on an initial 6 month contract. You will support the Quality Management System and help ensure compliance with regulatory requirements.

Working closely with Manufacturing, R&D, Regulatory Affairs, and Supply Chain, you will lead investigations into non-conformances, CAPAs, risk assessments, and validation activities to safeguard product quality.