Quality Engineer - Medical Devices

Location: North West, UK
Employment Type: Full-time
Industry: Medical Devices / Healthcare Technology

Are you a detail‑driven Quality Engineer with experience in both Quality Assurance and Quality Control within the medical device sector? We are recruiting on behalf of an innovative medical device organisation seeking a dedicated Quality Engineer to join their QARA (Quality Assurance & Regulatory Affairs) team.

This role is critical to maintaining product safety, compliance, and the continuous improvement of the Quality Management System (QMS). Reporting to the Senior Quality Engineer, you will work across supplier management, product inspection, QMS development, and cross‑functional support activities.

Key Responsibilities

Quality Assurance

• Lead supplier management activities including SCARs, KPIs, supplier assessments, audits, agreements, requalifications, and ongoing monitoring.
• Drive root cause investigations and corrective actions for NCMRs and CAPAs.
• Manage complaint investigations to identify root cause and implement corrective actions.
• Review and approve label specifications, equipment calibration records, preventive maintenance documents, and production documentation including DHRs.
• Manage the change control process.
• Support preparation and hosting of internal and external audits.
• Contribute to continuous improvement and implementation of QMS processes and documentation.
• Prepare data for QMS Management Review and QA metrics meetings.

Quality Control

• Inspect incoming and finished products.
• Inspect and release labels.
• Execute product release activities.

Essential Experience

• Experience working within ISO 13485 and 21 CFR Part 820‑compliant environments.
• Background in QA and preferably QC within a medical device company.
• Degree qualification or recognised quality qualification.

Desirable Experience

• Experience of working as a quality professional in the medical device industry.
• Strong track record in supplier evaluation and monitoring.
• Hands‑on experience with product inspection and release.
• Familiarity with complaint handling and non‑conformance processes.
• ISO 13485 Auditor training.

Key Competencies

• High attention to detail.
• Strong collaboration and teamwork skills.
• Excellent written and verbal communication.
• Analytical, critical thinking, and problem‑solving capability.
• Ability to work independently and in cross‑functional teams.