Quality & Validation Engineer
Quality Engineer / QA Validation Engineer / QE Validation Engineer
Location: West Midlands
Salary: £30,000 - £35,000
An exciting opportunity has become available for a Quality Engineer to join a Medical Device/Precision Manufacturing company based in the West Midlands on a permanent basis. This organisation are a growing business with an extremely stable team in place.
On a day to day basis the role will vary and be quite diverse with a strong emphasis on validation. Awareness and working knowledge of ISO 13485 is a requirement and experience within a manufacturing environment.
- Work closely with Production, Technical, Facilities, and Manufacturing Engineering departments on quality related matters such as; process control, improvement practices, and concern resolution to ensure customer and business requirements are met in a timely fashion
- Conduct internal audits, and participate in external and third party audits
- Provide technical expertise and knowledge on Validation to manufacturing group, QA, maintenance, design
- Be responsible for leading process validations onsite and be the subject matter expert for customer audits
- Be responsible for creating and maintaining Validation Master Plans and documentation.
- Create and put into action Validation documents / protocols for new process & equipment (DQ, IQ, OQ, PQ, PPQ)
- Assist with the creation of URS’s
- Create Work Instructions & SOP’s
- Maintain & promote GMP
- Ensure compliance to and maintenance of ISO 13485:2016
- Manage the CAPA process
Apply by sending your updated CV through and call Renee on . Interviews are being lined up at short notice.
Medical Devices / ISO 13485 / ISO 14971 / IQ OQ PQ / Validation / Risk Management