Senior Quality Engineer (Logistics)

JenaValve is transforming the treatment of aortic valve disease through innovative transcatheter heart valve technology. Our commitment to quality, innovation and patient safety drives everything we do.

As we continue to grow internationally, we are looking for an experienced Senior Quality Engineer to help ensure our products are delivered safely, compliantly and efficiently across our global supply chain.

As Senior Quality Engineer – Logistics, you will play a critical role in ensuring the quality, compliance and traceability of medical devices throughout the logistics and distribution process. Working closely with Operations, Supply Chain, Manufacturing and Regulatory teams, you will oversee logistics quality activities while supporting supplier quality management across our international supply chain.

This role offers the opportunity to make a significant impact on the performance and compliance of our global distribution network.

Based in Leeds, the position requires regular travel to Munich, and the Netherlands, together with occasional visits to suppliers and logistics partners.

You will:

• Ensure logistics, warehousing and distribution activities comply with ISO 13485, EU MDR 2017/745, FDA 21 CFR Part 820 and Good Distribution Practice (GDP).
• Maintain and continually improve Quality Management System (QMS) processes relating to logistics and distribution.
• Act as the Quality subject matter expert for logistics during internal and external audits.
• Ensure effective document control, change control and deviation management within logistics operations.
• Oversee quality requirements for product storage, packaging, labelling and shipment.
• Review and approve transport validation activities.
• Monitor environmental controls including temperature, humidity and storage conditions.
• Ensure full product traceability across the supply chain.
• Investigate non-conformances, deviations and customer complaints relating to logistics.
• Lead and support CAPA investigations and continuous improvement initiatives.
• Monitor logistics providers, warehouses and distributors to ensure ongoing compliance.
• Analyse quality metrics including delivery deviations, transport excursions and damage rates to identify improvement opportunities.
• Conduct supplier qualification and surveillance audits across the medical device supply chain.
• Develop supplier audit plans, assessment criteria and quality agreements.
• Support validation, equipment qualification and risk management activities.
• Prepare technical reports and quality documentation.
• Work collaboratively with cross-functional teams to ensure consistent regulatory compliance and operational excellence. 

• Bachelor's degree in Engineering or a relevant scientific discipline.
• Minimum five years' experience within Quality Engineering in the medical device, pharmaceutical or life sciences sector.

Strong knowledge of:

• ISO 13485
• EU MDR 2017/745
• FDA 21 CFR Part 820
• Good Distribution Practice (GDP)

• Experience conducting supplier audits and supplier quality management.

Proven experience managing:

• Non-conformances
• Root cause investigations
• CAPA
• Risk management
• Process validation

• Experience using ERP and Quality Management Systems (QMS).
• ISO 13485 Lead Auditor qualification (BSI or equivalent).
• FDA QSR / 21 CFR Part 820 audit training.
• Excellent analytical and problem-solving skills.
• Strong written and verbal communication skills.

• EU MDR training or qualification.
• Experience with logistics transport validation.
• Lean Manufacturing and Six Sigma knowledge.
• Experience working across international supply chains.

• A strong quality and compliance mindset.
• Excellent organisational skills and attention to detail.
• The ability to influence and build effective working relationships across departments.
• Confidence working independently and managing multiple priorities.
• A collaborative approach with the ability to engage stakeholders at all levels.
• A passion for continuous improvement and operational excellence.

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