At a Glance
- Tasks: Drive quality improvements and oversee new product introductions in a dynamic environment.
- Company: Join a world leader in consumer diagnostic products with a focus on innovation.
- Benefits: Enjoy hybrid working, 25 days leave, private medical insurance, and more.
- Other info: Work in a beautiful setting with excellent transport links and career growth opportunities.
- Why this job: Make a real impact in women's health through quality engineering.
- Qualifications: Experience in quality compliance, ideally in medical devices, with strong communication skills.
The predicted salary is between 45000 - 50000 £ per year.
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 and our brand Clearblue, recognised worldwide for 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 an 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, ensuring performance, compliance, and continuous improvement. Responsibilities include:
- Supporting and overseeing new product introduction and equipment transfer into manufacturing environments through validation and verification projects.
- Monitoring performance through KPIs and coordinating 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 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 is essential. Applicants must also have a passion for quality and 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 as 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.
Interested? Click apply and you will be redirected to our careers page to complete your application.
Senior Quality Engineer employer: SPD Development Company Ltd
Swiss Precision Diagnostics GmbH (SPD) is an exceptional employer, offering a dynamic work environment at our Innovation Centre in Bedford, where you can thrive as a Senior Quality Engineer. With benefits like hybrid working, generous annual leave, and a strong focus on employee health and wellbeing, we foster a culture of collaboration and continuous improvement. Join us to be part of a leading team dedicated to innovation in consumer diagnostics, while enjoying excellent growth opportunities and a supportive workplace.
Contact Details:
SPD Development Company Ltd Recruitment Team
