Senior Quality Engineer – In‑Vitro Diagnostics

About the role

We are seeking a Senior Quality Engineer to join our Quality team at the Innovation Centre in Bedford. You will lead quality planning and drive continuous improvement across contract manufacturers, packers and suppliers within the in‑vitro diagnostic (IVD) space.

Key responsibilities

• Develop and implement quality improvement initiatives and robust quality plans.
• Oversee supplier, contract manufacturer and packer performance, ensuring compliance with regulatory standards.
• Support new product introductions and equipment transfers through validation and verification projects.
• Monitor key performance indicators, manage non‑conformances (NC) and coordinate corrective and preventive actions (CAPA).
• Maintain the IVD Quality Management System (QMS) in line with ISO 13485, EU IVD Directive, MDR, IVDR and US FDA 21 CFR Part 820.

Required profile

• Proven experience in a quality or compliance function, preferably within medical devices or IVD.
• Strong knowledge of ISO 13485:2016 and US FDA 21 CFR Part 820.
• Excellent communication skills and ability to build effective working relationships.

Required skills

• ISO 13485
• US FDA 21 CFR Part 820
• EU IVD Directive 98/79/EC
• Medical Device Regulation 2017/746
• MDSAP
• Internal and external auditing
• Validation and verification methodologies

What we offer

• Hybrid working model
• 25 days paid annual leave plus bank holidays (pro‑rated)
• Competitive pension scheme
• Private medical insurance with cash plan
• Enhanced maternity and paternity pay
• Health & wellbeing programme and life assurance
• Free electric car charging points and a parkland setting with excellent transport links