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 Senior Quality Engineer - Innovation 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 in to the Quality Manager - Innovation, this role has accountability for Quality system activities relating to Innovation at SPD, including but not limited to:
- Product Design and Development
- Product Changes
- Concept Innovation
- New Product Initiatives (NPI).
We're looking for someone who has experience of ensuring quality and compliance within a medical device environment. Applicants must have sound knowledge of ISO 13485 Council Directive 98/79/EC, In-Vitro Diagnostic Medical Device Regulation 2017/746, US FDA 21 CFR Part 820, IEC 62304, Usability and other worldwide regulatory and compliance standards.
The ideal candidate would have experience of Quality assurance of Software as a Medical Device and Design Control for IVD's. Candidates with software experience but not in the medical devices industry would be considered, as would a combination of Medical Device design control without software experience.
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. 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.