Quality Engineer

Chepstow Permanent
  • Fantastic opportunity to join a rapidly expanding medical device company
  • Offering a highly competitive basic salary

About Our Client

The client are an international medical device company developing cutting-edge technology. They are rapidly expanding with ongoing acquisitions and with new offices being established in Europe and the US.

Job Description

As a Quality Engineer you will:

  • Work with the product development teams to create a robust and compliant Product Quality Plan
  • Verify that project teams are operating in compliance with plan and internal Standard Operating Procedures for new product development
  • Offer pragmatic guidance to the project teams on creating robust documentary evidence to support compliance and timely achievement of project goals
  • Support the risk management process with the project teams to ensure that there is a favourable risk/benefit ratio and suggest plans and strategies for reduction of risk
  • Develop the master validation plan with the project team for the introduction of manufacturing equipment and processes into production
  • Review and approve validation protocols including IQ, OQ and PQ, providing support for any statistical techniques and analysis required

The role will be based primarily on-site in Chepstow.

The Successful Applicant

As the successful candidate you will have:

  • Previous experience in a Quality Engineering, Quality Assurance or Regulatory role (working with class II or III medical devices is desirable)
  • Experience of supporting new product development teams in a quality role i.e. supporting them through the regulatory pathway from the definition of a project to release to market
  • An understanding of process validation, process control and electronics manufacturing techniques
  • Knowledge / an understating of relevant regulations (ISO 13485, FDA 21CFR part 820, ISO 14971, ISO 10993)
  • A sense of urgency - make things happen/get results

What's on Offer

The client are looking for the right candidate to join their rapidly expanding business where you can grow and develop your skill-set as the company drives forward. They are offering a competitive rate of pay and offer a friendly, positive culture.

Jason Hines
Quote job ref
Phone number
+44 172 773 0102

Job summary

Contract type
Consultant name
Jason Hines
Consultant phone
+44 172 773 0102
Job reference