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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.
Job Responsibility:
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
Inspect incoming and finished products
Inspect and release labels
Execute product release activities
Requirements:
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
Nice to have:
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