Quality Engineer - Design Assurance

SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between Procter & Gamble (P&G) and Abbott; and our brand Clearblue, is recognised the world over as providing accurate home pregnancy and fertility monitoring tests.

We are looking for a Quality Engineer, Design Assurance to join our Quality team on a Permanent, Full-Time contract.

The role will be based at our Innovation Centre in Bedford, UK with option for Hybrid Working.

The Quality Engineer's focus is supporting compliance of SPD's Innovation projects to all required standards and regulations. The role holder will also perform general Quality Assurance duties as required in support of fulfilment of the Quality Objectives.

The role works within an In-Vitro Diagnostic Quality Management System (QMS) and complies with ISO 13485, Council Directive 98/79/EC, In-Vitro Diagnostic Medical Device Regulation 2017/746, US FDA 21 CFR Part 820 and other worldwide regulatory and compliance standards.

We're looking for someone who has experience of working within a medical device environment with working knowledge of ISO 13485. Applicants must also have a passion for quality and design assurance and be able to demonstrate excellent communication skills with the ability to build effective working relationships.

Working knowledge of software as a medical device is desirable along with working knowledge of US FDA 21 CFR 820, EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC.

We can offer you

• Competitive salary and bonus
• Hybrid working with flexibility
• 25 days paid annual leave plus bank holidays
• Company pension scheme with competitive employer contribution
• Private Medical Insurance with additional Medical Cash Plan
• Enhanced maternity and paternity pay
• Company supported employee Health & Wellbeing programme
• Life assurance
• Free electrical car charging points
• Free parking
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes Northampton and London

You must have the right to work in the UK. SPD are not able to provide sponsorship for this role.

If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help.

We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.