QC Team Leader

Summary

Walker Cole International is supporting a leading medical device manufacturer, in their search for an experienced Team Leader, Quality Control to join their site in West Yorkshire.

This is a hands-on leadership role within the Incoming Quality Control and Receiving Inspection function, reporting to the Quality Control Manager. The successful candidate will lead a team of inspectors and technicians responsible for the inspection, testing and disposition of incoming materials, components, sub-assemblies and finished products, ensuring compliance with the company's Quality Management System, ISO 13485, EU MDR 2017/745 and FDA 21 CFR Part 820 requirements while driving quality excellence and continuous improvement across the operation.

Your Responsibilities as Team Leader, Quality Control

• Lead and supervise a team of Quality Control Inspectors, Quality Control Technicians, and Receiving Inspection Technicians, providing daily technical guidance, workload allocation and operational oversight.
• Report on inspection performance, quality metrics, resource requirements and non-conformance trends to the Quality Control Manager.
• Identify training needs and coordinate competency development and qualification activities.
• Serve as the primary technical escalation point for complex inspection decisions and specification interpretation.
• Review, approve and authorise inspection records and product dispositions within delegated authority.
• Ensure all final valve inspections and testing activities are completed accurately, efficiently and in compliance with regulatory requirements.
• Conduct routine testing activities on transcatheter heart valve products, including functional testing, measurements, verification, visual inspection and final product release.
• Support supplier quality activities through review and approval of incoming documentation.
• Perform First Article Inspection (FAI) activities to verify compliance with engineering drawings and manufacturing specifications.
• Drive continuous improvement initiatives within manufacturing and inspection processes, and promote a culture of quality, compliance, accountability and operational excellence.
• Support cross-functional business activities as required, and comply with all Health & Safety and cleanroom requirements.

Your Background as Team Leader, Quality Control

• HNC, HND or Degree in Engineering or a related technical discipline.
• Strong working knowledge of ISO 13485:2016, EU MDR 2017/745 and FDA 21 CFR Part 820.
• Minimum of three years' experience in a Team Leader or supervisory role.
• Minimum of three years' experience in receiving / incoming quality inspection within a regulated manufacturing environment.
• Strong leadership, coaching and people management skills, with excellent verbal and written communication skills.
• Ability to prioritise workloads and effectively deploy resources, with strong analytical and problem-solving abilities.
• Comfortable working hands-on within manufacturing and quality operations, with proven ability to collaborate effectively across cross-functional teams.
• Desirable: Degree-level qualification in Quality Engineering, Manufacturing Engineering or a related field; formal training or certification in ISO 13485, EU MDR 2017/745 or FDA 21 CFR Part 820; experience within Class II or Class III medical device manufacturing environments.

Working Environment

This position is based in West Yorkshire and involves working within both office and cleanroom environments. The successful candidate must be able to work in a controlled cleanroom environment while wearing full cleanroom gowning and PPE, follow strict contamination control, quality and safety procedures, and operate effectively in a highly regulated medical device manufacturing setting.

Team Leader | Quality Control | Incoming Quality Control | Receiving Inspection | Medical Devices |ISO 13485 | EU MDR 2017/745 | FDA 21 CFR Part 820 | First Article Inspection | Cleanroom | Supplier Quality | Quality Assurance | Manufacturing

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