Product Features
Blog
Contact Us
Sign In
SPD Development Company Limited
,
Bedford, Bedfordshire
Senior Quality Engineer
|
|
Job Type: Full-time |
|---|
Overview
An exciting opportunity has arisen for a Senior Quality Engineer to join our Quality Team at SPD, reporting directly to the Quality Manager - Manufacturing . This is a full time, permanent position based at our Bedford site. The role holder’s focus will be to assure Quality and Compliance of products and processes managed by SPD’s Contract Manufacturing partners, including Device Manufacturers, EMS providers and Contract Packagers. Main Responsibilities Ownership and coordination of Contract Manufacturer product and process change control activities to assure changes are managed in an effective, efficient and compliant manner. This includes the coordination of appropriate risk management, customer and stakeholder notification, technical review and updates to design and technical file documentation as appropriate. Ownership and development of Contract Manufacturer monitoring and reporting systems , including the identification and implementation of improvement opportunities. Management of Quality Assurance activities for third-party sourcing projects , including the development of processes and systems to assure compliance. Management of Contract Manufacturer non-conformances including the coordination of appropriate SPD review or escalation, oversight of investigations and corrective actions, documentation and reporting. Provide support to assure the effective transfer of new products from R&D into manufacturing Provide support in the fulfilment of internal and external audits against published plans. Deputise for the Quality Manager - Manufacturing as required. Some travel may be required. Person Specification Essential Minimum or 5 years’ experience, ideally within a Medical Device environment . Working knowledge of ISO 13485:2016 and US FDA 21 CFR 820 Auditing experience within the scope of the above standards/regulations Desirable Ideally would have some knowledge &/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 What we can offer you 25 days paid annual leave (plus bank holidays) Enhanced Maternity and Paternity Pay Private Medical Insurance Medical Cash Plan Scheme Company Pension Scheme Life Assurance Employee Health and Wellbeing Programme Free Parking and Electric Car Charging Points Parkland Setting If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help. About SPD Swiss Precision Diagnostics (SPD) was formed in 2007 as a joint venture between Procter & Gamble (P&G) and Alere, now a wholly owned subsidiary of 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. 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.