Quality Engineer

4 weeks ago

Witney Oxfordshire, United Kingdom Cure Talent Full time

Cure Talent is thrilled to partner with a renowned global MedTech company with an impressive legacy spanning over a century

This industry-leading organisation is dedicated to revolutionising lives through innovative healthcare solutions. Due to ongoing growth, an exciting opportunity has arisen for a Quality Validation Engineer to join our team, with a particular focus on equipment validation.

As the new Quality Validation Engineer you will be responsible for creating, developing and providing support for validation strategies, in particular with Equipment Validation. You will create process validation and equipment qualification requirements and will review qualification and validation protocols.

To be successful in this role you will have proven Quality and Validation Engineering experience in a highly regulated environment, ideally Medical Devices with in-depth experience of creating and developing Validation Strategies. You will ideally have experience of one or more of Equipment, Facilities, Utilities and/or Non-Product Software.

Key Responsibilities:

  • Create, develop and provide support for validation strategies.
  • Create process validation and equipment qualification requirements (IQ, OQ, PQ).
  • Review qualification/validation protocols.
  • Establish and maintain the status of the site validation system.
  • Assist in change control documentation implementation and contribute to risk management reports.

Essential Skills, Knowledge & Experience:

  • Proven experience of Validation of Equipment, Facilities, Utilities and/or Non-Product Software.
  • Proven experience within a highly regulated manufacturing environment (Medical Devices, Pharma, Aerospace etc.)
  • Proven knowledge and experience of Change Control and Risk Management processes.
  • Engineering or Scientific Degree is highly advantageous.
  • Knowledge and experience of ISO 13485 & ISO 14971 is highly advantageous.

If you're seeking an exciting opportunity to be part of a dynamic team driving medical technology innovation, don't miss out – get in touch today

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