Quality Engineer

Posted 25 September by AES
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Position: Quality Engineer

Location: Cambridgeshire

Salary: £40,000 to £55,000 + Excellent Benefits / Prospects (including Relocation Assistance)

If there is something stopping you from achieving all you’re capable of, you’ll relish a role with a company that will positively encourage you to be pro-active - a real opportunity to release your true potential.

The Company: Our Client, an innovative dynamic passionate manufactures minimal invasive next-generation robotic-assisted medical devices that are at the forefront of how surgical procedures are carried out. An award-winning company that plans to significantly disrupt the way surgery is performed for the benefit of millions of patients all around the world.

Due to sustained continued expansion they now require a Supplier Quality Engineer to work within the routine quality group acting as an auditor and a liaison to suppliers over routine and quality issues. It will be your responsibility to develop a strong partnership with the Supplier Quality Assurance group and the procurement teams. Other responsibilities include, but are not limited to:

  • Maintain good relationships with Supply Chain, Engineering, Manufacturing, and R&D departments.
  • Assess suppliers either remotely or on site.
  • Facilitating corrective action and preventive actions aimed at addressing supplier quality issues, this includes ensuring appropriate investigations associated with product, supplier performance, and complaints
  • Facilitating RoHS and REACH compliance
  • Generating, reviewing and approving of supplier quality-related support documentation
  • Reporting supplier performance and quality to management
  • Reviewing supplier component documentation including 8Ds, dimensional and material reports for sign off acceptance.
  • Working with Supply Chain and suppliers to facilitate New Product Introduction to include witnessing production component readiness i.e. Installation Qualification, Operational Qualification and Performance Qualification runs’

The Person: Candidates suitable for consideration should be able to provide evidence of the following:

  • A Degree/HND in Engineering or be a Time Served Engineer with relevant experience.
  • Experienced quality professional with a broad knowledge of manufacturing processes & validation (IQ / OQ / PQ)
  • Strong audit background / Lead auditor with ISO 13485 or CFR 820 experience.
  • A thorough understanding of Quality Management Systems (ideally the requirements of ISO13485 and FDA 21 CFR part 820)
  • Previous experience of working within Medical Devices (desirable)

You will be self-motivated, have excellent communication skills both written and oral, be computer literate, and able to work as part of a team.

The successful candidate will enjoy a salary of between £40,000 to £55,000 (DOE) + Excellent Benefits / Prospects (including Relocation Assistance) plus excellent prospects and an employment package that you would expect from a company that values its employees.

Do you have the courage to take on this challenge?

Required skills

  • Medical Devices
  • Quality Management
  • Supplier Development
  • Supplier Quality
  • Supplier Quality Management

Reference: 40714820

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