Our client is a leading medical technology company that designs radiation delivery devices to support clinical teams and cancer researchers. For more than 25 years, they have been shaping the development of superficial and orthovoltage radiation therapy and advancing preclinical radiation research. They are seeking Quality Engineer who will work with the production team to ensure that the parts delivered from suppliers meet the design specifications and quality requirements.  This engineer will help with production in supplier quality assessments including creating and following up on SCARs. The Engineer will also ensure that the Device History Record (DHR) is up to date for products manufactured.  The Quality Engineer will play a key role in ensuring the document control, CAPA, and the complaints process is followed effectively. Quality Engineer Monday– Friday (9am – 5pm) Walsall (On site 5 days a week) Quality Engineer Job Description Key Accountabilities: 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 theirdisposition: repairs, scrap, rework, return to vendor. Ensure all required documentation for the returned items are created. Quality: The Quality Engineer will support the QARA team in: CAPA Process: Creating, tracking, and closure of CAPAs. Working with the CAPA action owners to ensure closure ofaction 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. Quality Engineer Key Skills 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. Quality Engineer Benefits 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 1 day per week remote.