Team Leader, Quality Control

As Team Leader, Quality Control, you will provide day-to-day leadership and technical expertise within our Incoming Quality Control and Receiving Inspection function. Reporting directly to the Quality Control Manager, you will lead a team of inspectors and technicians responsible for the inspection, testing, and disposition of incoming materials, components, sub-assemblies, and finished products.

You will ensure compliance with JenaValve's Quality Management System (QMS), ISO 13485, EU MDR 2017/745, and FDA 21 CFR Part 820 requirements while driving quality excellence and continuous improvement across the operation.

• Lead and supervise a team of Quality Control Inspectors, Quality Control Technicians, and Receiving Inspection Technicians.
• Provide 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.
• Promote a culture of quality, compliance, accountability, and operational excellence.
• Support cross-functional business activities as required.
• Comply with all Health & Safety and cleanroom requirements.

• 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 3 years' experience in a Team Leader or supervisory role.
• Minimum of 3 years' experience in receiving / incoming quality inspection in a regulated manufacturing environment.
• Strong leadership, coaching, and people management skills.
• Excellent verbal and written communication skills.
• Ability to prioritise workloads and effectively deploy resources.
• Strong analytical and problem-solving abilities.
• Comfortable working hands-on within manufacturing and quality operations.
• Proven ability to collaborate effectively across cross-functional teams.

• 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.

This position is based in Leeds 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.
• Operate effectively in a highly regulated medical device manufacturing setting.

Salary: Subject to experience

Benefits:

• Company pension
• Free parking
• AXA Private medical insurance
• Employee Referral program
• Company sick pay
• 28 days holiday plus public holidays
• Discretionary corporate bonus