Quality Engineer - Design Assurance

Swiss Precision Diagnostics GmbH; Bedford; Hybrid; GBP 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a Quality Engineer to join their dynamic team in Bedford. This exciting role focuses on ensuring compliance with industry standards in the development of advanced diagnostic products. You will be at the forefront of quality assurance, working within a robust Quality Management System and engaging with various regulatory frameworks. The company offers a hybrid working model, competitive salary, and a range of benefits including private medical insurance and generous leave. If you have a passion for quality and a background in medical devices, this opportunity is perfect for you.

Benefits

Competitive salary and bonus

Hybrid working with flexibility

25 days paid annual leave plus bank holidays

Company pension scheme

Private Medical Insurance

Enhanced maternity and paternity pay

Health & Wellbeing programme

Life assurance

Free electrical car charging points

Free parking

Qualifications

• Experience in a medical device environment with knowledge of ISO 13485.
• Proven ability to build effective working relationships.

Responsibilities

• Support compliance of innovation projects to required standards.
• Perform general Quality Assurance duties to meet Quality Objectives.

Skills

Quality Assurance

ISO 13485

Communication Skills

Medical Device Regulations

Education

Degree in Engineering or related field

Tools

In-Vitro Diagnostic Quality Management System (QMS)

US FDA 21 CFR Part 820

EU IVD Directive 98/79/EC

Job description

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.