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Quality Assurance Specialist

2 months ago

London, Greater London, United Kingdom KaneHR Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at KaneHR. As a Quality Assurance Specialist, you will work closely with the production team to ensure that all parts delivered from suppliers meet the design specifications and quality requirements.

Key Responsibilities:
  • Ensure suppliers meet quality standards as specified in supplier quality agreements
  • Review and create production feedback reports, NCRs, and CAPAs for product and process issues found in production
  • Verify all incoming parts from suppliers meet design specifications and quality requirements before accepting them for production
  • Create SCARs on non-confirming parts/components and follow up with suppliers to ensure corrective actions are effective
  • Review Device History Records (DHRs) for completeness before authorizing shipment of products
  • Create production feedback reports for product or process issues found during production
  • Manage customer return process and ensure returned parts are dispositioned according to quality management system requirements
  • Support the QARA team in CAPA process, document control process, and complaints process
Requirements:
  • Experience working in a medical device industry as a quality engineer is required
  • Working knowledge of ISO 13485 and ISO 14971
  • Experience working with manufacturing/production in quality control
  • Knowledge of processes for transition from EU MDD to EU MDR is a plus but not mandatory
What We Offer:
  • Full-time, permanent role
  • Competitive salary between £30,000-£35,000 depending on experience