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- Gatekeeper for all incoming parts / components.
- Ensure suppliers are meeting the quality standards as specified in supplier quality agreements.
- Ensure Production Feedback Reports, NCRs, and CAPAs are created for product and process issues found in Production.
- Ensure customer returns, document control, and complaint process is adhered to.
- Incoming inspection of components / parts.
- Defining sampling criteria for incoming inspection.
- Verify Certificate-of-Compliance from suppliers for their accuracy and completeness.
- Ensure all non-conforming components / parts are accounted for and quarantined.
- Create SCARs on non-conforming parts / components. Follow up with suppliers on SCARs ensuring corrective actions are effective.
- Review DHRs for their completeness before authorising shipment of products.
- Create / help create Production Feedback Reports for product or process issues found during production.
- Create Non-Conformance Reports (NCRs) and / or Supplier Corrective Action Reports (SCARs) as applicable.
- Create RMAs for customer returned items.
- Track the returned items for their disposition: repairs, scrap, rework, return to vendor.
- Ensure all required documentation for the returned items are created.
- CAPA Process:
- Creating, tracking, and closure of CAPAs.
- Working with the CAPA action owners to ensure closure of action items
- Document Control Process:
- Maintaining effectiveness of the document control process by managing documents throughout their lifecycle (from creation to obsolescence).
- Ensuring accuracy, completeness, and need-to-know basis access control to meet quality and regulatory requirements.
- Complaints Process:
- Ensuring effective management of customer feedback.
- Working with inter-departmental team to investigate and find root cause of the issues.
- Contributing to risk analysis and reportability assessment.
- Supplier:
- Onboarding of new suppliers.
- Reviewing supplier revaluation documentation.
- Experience of working in a medical device industry as a quality engineer.
- Working knowledge of ISO 13485 and ISO 14971.
- Experience working with manufacturing / production in quality control.
- Knowledge in processes for transition from EU MDD to EU MDR is a plus but not mandatory.
- Bonus every year, based on company profit (was about £700 last year)
- Pension – 5%:3% (candidate needs to put 5% in)
- 23 days holiday +bank holidays
- Health cash plan
