- 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.
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.