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Process Validation Engineer

Serve Talent
Job LocationMildenhall, Bury St. Edmunds
EducationNot Mentioned
Salary35,000 - 40,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent,full-timeP

Job Description

Serve Talent are proud to be working exclusively with a successful Medical Device manufacturing business who are looking to recruit a Quality Processing and Validation Engineer for their facility based in Mildenhall, Suffolk.Reporting into the Head of Medical and working alongside the wider Research & Development team, youll lead process validation activities across both medical and non-medical businesses as well as writing and executing various types of documentation to achieveregulatory approvals for medical devices and non-medical processes.Responsibilities will include but not be limited to:

  • Provide support with generating documentation relating to the manufacture and validation of medical devices.
  • Generating project documentation in line with ISO 13485 and other medical device regulatory requirements.
  • Providing QA support for the implementation of ISO 13485:2016 and ISO9001: 2015
  • Perform Tooling and manufacturing validation and equipment qualification for both medical and non-medical products and processes
  • Work closely with colleagues and customers to support the integration and validation of production lines of new medical devices and the management of existing non-medical equipment and processes.
Ideally youll have:
  • Experience with Medical Devices.
  • Documentation generating qualities, skills and cross-functional teamwork.
  • EU 2017/745 MDR, ISO13485 & ISO14971 knowledge.
  • Knowledge of Regulatory and QA systems.
This is a fantastic opportunity for a regulatory focused person to take the next step in their career, by joining an established team of experienced Engineers and developing your career long term.Alongside a competitive salary and benefits package, is a carved out career development plan with significant scope for promotion and development for those who want it.If you have the skills and experience required and would like to be considered, apply now!

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