Quality & Validation Engineer

Recruiter
X4 Group
Location
Warwickshire
Salary
£30,000 per annum
Posted
30 Aug 2017
Closes
21 Sep 2017
Sector
General
Contract Type
Full Time

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.

Responsibilities:

  • 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