Senior Quality Engineer

SPD Development Company Ltd; Bedford; Hybrid; GBP 45,000 - 50,000; Full time

Benefits offered by this job

25 days annual leave + bank holidays

Company pension scheme

Private Medical Insurance

Enhanced maternity/paternity pay

Health and Wellbeing programme

Life assurance

Electric car charging points

Parkland setting, good transport links

Job summary

Swiss Precision Diagnostics GmbH (SPD) in Bedford, UK, seeks Senior Quality Engineer to drive quality improvements and oversee supplier quality in a medical device environment. The role offers hybrid working, permanent full-time, and benefits.

You will ensure compliance with ISO 13485, US FDA 21 CFR Part 820, and other standards, coordinating internal and supplier audits and CAPA processes. The successful candidate will have experience in quality and compliance within medical devices, strong

Qualifications

• Experience in quality and compliance within a medical device environment.
• Working knowledge of ISO 13485:2016 and US FDA 21 CFR Part 820.
• Ability to drive quality improvements and coordinate audits.
• Experience with supplier audits and CAPA closure.

Responsibilities

• Drive quality improvements through meticulous quality planning.
• Oversee contract manufacturers, packers and suppliers for performance.
• Support new product introduction and equipment transfer via validation and verification.
• Monitor KPIs and coordinate NC/CAPA resolution.
• Ensure compliance with ISO 13485 and MDR/IVDR directives as applicable.

Skills

Quality management

Auditing

CAPA process

Regulatory knowledge

Stakeholder comms

Job description

Senior Quality Engineer

Salary: £45,000 – £50,000 per annum DOE plus benefits

Location: Bedford

Full-Time, Permanent

The Vacancy

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 Senior Quality Engineer 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 Senior Quality Engineer’s focus is to drive quality improvements through meticulous quality planning. The role holder will drive quality oversight of contract manufacturers, packers, and suppliers, driving performance, compliance, and continuous improvement. Support and oversee new product introduction and equipment transfer into manufacturing environments through validation and verification projects. Monitor their performance through KPIs and coordinate the effective and timely resolution of any NC or CAPA.

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 quality and compliance function, ideally within a medical device environment. Working knowledge of ISO 13485:2016 and US FDA 21 CFR Part 820.

Applicants must also have a passion for quality and be able to demonstrate excellent communication skills with the ability to build effective working relationships.

Working knowledge of EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC, Medical Device Regulation 2017/745 or In Vitro Diagnostic Regulation 2017/746 and Medical Device Single Audit Program (MDSAP) is desirable along with experience of being an internal or external auditor as the role provides support in the fulfilment of external audits against the supplier audit plan.

We can offer you:

• Hybrid working
• 25 days paid annual leave plus bank holidays (pro-rata)
• Company pension scheme including competitive employer’s contribution
• Private Medical Insurance package with additional medical cash plan scheme
• Enhanced maternity and paternity pay
• Company supported employee Health and Wellbeing programme
• Life assurance
• Free electrical car charging points
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road and rail)

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.

The Company

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.