Senior Quality Engineer – Medical Devices

£35k- £40k per year + benefits

Mildenhall, Suffolk

Serve Talent have partnered with a successful Engineering business to recruit a Senior Quality Engineer for their manufacturing facility based in Mildenhall, Suffolk.

You’ll mainly be tasked with providing support in implementing and maintaining the companies QA Systems. You’ll also be writing and executing various types of documentation to achieve the correct regulatory approval for a range of innovative medical devices and processes.

As part of the development of these medical devices, the quality department play a key role. Some of these devices could potentially save peoples lives so making sure the t’s are crossed and the i’s dotted is essential.

Responsibilities will include but not be limited to:

  • To provide support with generating documentation relating to the manufacture 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.
  • Play an active role in Continuous improvement.

Ideally you’ll have:

  • ISO 9001 experience.
  • Experience of working in a Quality role within a manufacturing or engineering environment.
  • Ideally a qualification for internal auditing to ISO9001:2015.
  • Ideally strong project leadership/management skills.
  • Validation experience would be great but not essential.

This is a fantastic opportunity for a Quality focused person to take the next step in their career, by joining an established team of experienced individuals 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!