Senior Quality Engineer - EQMS Implementation FTC
SPD are currently recruiting for a Senior Quality Engineer who has experience in project management to join our UK based Quality team. Reporting directly into the Quality System Manager, this role is accountable for implementing a new EQMS at SPD whilst maintaining compliance to ISO 13485, IVDR, IVDD, FDA, with the support of the software provider & Quality System Manager. This role works within an In-Vitro Diagnostic Quality Management System (QMS) and complies to the requirements:
- ISO 13485
- Council Directive 98/79/EC
- In-Vitro Diagnostic Medical Device Regulation 2017/746
- US FDA 21 CFR Part 820
- Other worldwide regulatory and compliance standards
This position is a full time, 6 month Fixed Term Contract role within SPD and will be based at our Innovation Centre in Bedford, UK once COVID restrictions allow.
- Supporting successful execution of contracts and legal agreements
- Generation of a project plan for execution
- Validation (IQ/OQ/PQ)
- Migration of current system
- All related training
- Setting user roles and permissions
- Working with key stakeholders, assuring that the new EQMS meets the needs of the business (Geneva, Bedford)
- Generation of business process, work instructions and forms
- Ensuring that once tenure is complete, all records are maintained in accordance with the SPD record retention policy and EQMS knowledge is transferred to local QMS Team
- Other related task as deemed necessary by the Quality System Manager
- 5+ years' within a quality and compliance function, ideally within a medical device environment
- Working knowledge of ISO 13485:2016 and US FDA 21 CFR 820
- Excellent project management skills
- Ability to solve problems and execute solutions to problems/issues identified
- An ability to build strong working relationships
- Self-motivated and able to plan and manage own workload
- Ideally undertaken a Train the Trainer programme and have a qualification or experience of delivering training
- Ideally would have some knowledge and/or experience in the following:
- 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
- Medical Device Single Audit Program (MDSAP)
What we can offer you
- Generous 25 days paid annual leave plus bank holidays (pro rata)
- Company pension scheme including employer's contribution
- Excellent Private Medical Insurance package with additional medical cash plan scheme
- Enhanced maternity and paternity pay
- Company supported employee Health & Wellbeing programme
- Life assurance
- FREE parking including free electrical car charging points & disabled parking facilities
- 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.
Swiss Precision Diagnostics (SPD) was formed in 2007 as a joint venture between Procter & Gamble (P&G) and Alere (now Abbott) to create, using its parent companies' complementary strengths, one of the world's foremost organisations in consumer diagnostics.
We are a leading supplier of home pregnancy and fertility/ovulation tests. Our brands include Clearblue. These are products designed to give women a better understanding of their own reproductive health and invaluable guidance in their family planning. Our research interests are in the broad application of innovative technologies for use by the consumer at home. We have a strong focus on women's reproductive health and our goals are in the continuing supply of useful diagnostic products which are accurate, simple and affordable. In the achievement of these goals, we believe that SPD consumer diagnostic products will make increasing contributions to personal healthcare and well-being.
SPD's Head Office is based in Geneva, Switzerland, and our Innovation Centre is based in Bedford, UK. SPD employs around 180 people.