Quality Manager – Design Assurance
Swiss Precision Diagnostics (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 Manager – Design Assurance to join our Quality team on a Full-Time, Permanent basis.
The role will be based at our Innovation Centre in Bedford, UK with option for Hybrid Working.
Reporting to the Global Quality Director, the Quality Manager – Design Assurance has overall accountability for the Quality system activities relating to Product Design and Development, Design Transfer, Product Changes, Concept Innovation and New Product Introductions (NPI).
The Quality Manager – Design Assurance is responsible for leadership and management of the Quality Design Assurance Team, ensuring that the QMS relating to Design Control and Software as a Medical Device is established and maintained to comply with current business, Quality & Regulatory requirements. In addition, the role has responsibility for the continuous improvement of the QMS to meet changing external requirements and the ongoing needs of the business.
We’re looking for someone who has experience of working within a medical device environment with experience of Design Control and Software as a Medical Device in the Medical Device Industry. Applicants must have sound knowledge of ISO 13485:2016, US FDA 21 CFR 820 & ISO 14971:2019, and ideally EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC and Medical Device Regulation 2017/745 or In Vitro Diagnostic Regulation 2017/746. Experience in Medical Device Single Audit Program (MDSAP) is desirable.
The role holder will be expected to understand and adapt to their audience so good interpersonal skills and excellent written and oral communication skills are essential. They are also expected to have proven effective people manager experience. Having the ability to communicate persuasively to gain commitment will be advantageous along with the ability to drive compliance as a competitive advantage.
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 & Wellbeing programme
* Life assurance
* Free electrical car charging points
* Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road & 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.