Get Staffed Online Recruitment Limited
Senior Quality Engineer
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Senior Quality Engineer
Salary: £45,000 - £50,000 per annum DOE plus benefits
Location: Bedford
Type: Full-Time, Permanent
The Vacancy
Our client is a world leader in the research, design, and supply of advanced consumer diagnostic products. They are a joint venture, and their brand is recognized worldwide for providing accurate home pregnancy and fertility monitoring tests.
They are looking for a Senior Quality Engineer to join their Quality team on a permanent, full-time contract. The role will be based at their Innovation Centre in Bedford, UK, with the option for hybrid working.
Responsibilities
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, driving performance, compliance, and continuous improvement. Support and oversee new product introduction and equipment transfer into manufacturing environments through validation and verification projects. Monitor their performance through KPIs and coordinate 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.
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Requirements
- Experience of 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.
- Passion for quality and 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.
- Experience of being an internal or external auditor as the role provides support in the fulfillment of external audits against the supplier audit plan.
Benefits
- 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 an 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)
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They are an equal opportunity employer and value diversity. They do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, or disability status.
The Company
Our client is a world leader in the research, design, and marketing of advanced consumer diagnostic products. Their research center 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. They are committed to answering the needs of their existing and future consumers through a continuous flow of new and innovative products.
Interested?
Click apply and you will be redirected to our client's careers page to complete your application.
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