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Quality Engineer

AES
Job LocationCambridgeshire
EducationNot Mentioned
Salary£40,000 - £55,000 per annum, inc benefits, OTE
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Position: Quality EngineerLocation: CambridgeshireSalary: £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

    • Keyskills :
    Medical Devices Quality Management Supplier Development Supplier Quality Supplier Quality Management

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