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.


Due to internal promotion, 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 supporting compliance of Quality activities relating to Design Assurance including Documentation and Device Design Change Control across areas of the business including Concept Innovation, New Product Introductions (NPI), Transfer to Manufacturing and Software as a Medical Device. 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.

SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products.


Our SPD research centre is at the cutting edge of innovation, and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.