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Senior Quality Engineer - Leeds

£25 - £38/hour

Leeds

Preetha Sampath is recruiting for a Quality Engineer to work for a medical device company that manufacture a prestigious range of neuro and orthopaedic products. The Quality Engineer will be working at their state of the art site in Leeds on a 6 month contract basis. This client is provideing an opportunity to be involved in pioneering projects that are truly making a difference to peoples lives everyday, worldwide. The primary function of the Quality Engineer job will be to report to the Design Quality Engineering Manager and lead the product development efforts. The Quality Engineer should have the following skills and experience:
-Lead product development activities from a Technical Quality perspective by preparing appropriate Risk Management plans, reviewing Design Control plans and overseeing qualification and validation process with internal manufacturing sites an.or external suppliers. -Supporting risk assessment activities:
Develop and utilise DFME. PFMEA and other QA risk analysis techniques in order to minimise potential risk during developmen.implementation activity. -Support the product post market surveillance process from a technical Quality perspective. - Ensure effective problem analysi.complaint investigation (CAPA) as needed and define through negotiation effective corrective actions. - Lead QA input in Design for Manufacture activities. - Working with relevant business stakeholders, support and lead in the Non-Conformance (NC), Corrective And Preventative Action (CAPA) investigations and general problem solving for both design and process. - Ensure compliance with all Documented Quality system, as per FDA QSR`s and ISO 1348.9001 requirements etc. during day to day activities. The ideal job job candidate is required to have the following Qualifications, Skills and Experience:
- A degree level or similar qualification in mechanical or industrial engineering. - Creation an.or maintenance elements of Quality Systems. - Proven capability to successfully introduce new product development in the Medical Device Industry. Proven understanding and capability regarding product verification and process validations. - Proven understanding of FDA and GMP requirements regarding medical Devices. - Knowledge and understanding of validation techniques such as risk assessment, validation planning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), change control and process verification. Please note that your curriculum vitae (CV) should show exact dates of employment (month and year) and any gaps of a month or more should be explained. CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria. If you do not hear back from us within 5 working days of your application for this job, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ENG40305 in all correspondence

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