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Quality Engineer

Reference Number: 924506 | Location: Essex, United Kingdom | Division: Scientific Permanent

Quality Engineer

Medical Devices – Essex

£30,000 - £42,000

The opportunity

Our client is searching for an experience quality engineer to focus on driving sustainable process improvements. The role is responsible for developing, monitoring and implementing all quality attributes for assigned programs and products to ensure compliance with Company, customer contractual requirements, regulatory requirements, specifications and drawings requirements.

The company

Our client is a small medical device manufacturer working on specialised medical products for a range of customers within the pharmaceutical and medical device sectors. They use the latest technology as well as the highest quality materials, to provide innovative products to improve the lives of people all around the world.

Responsibilities and duties

  • Lead corrective actions using root cause analysis investigations such as 8D
  • Assess quality performance using statistical and analytical methods
  • Ensure that documentation is compliant with requirements
  • Develop and establish advanced quality systems and procedures
  • Be able to act as main contact for internal and external audits
  • Develop and coordinate CAPA procedures and plans

Required experience

  • Familiar with the applications of medical device industry requirements of ISO9001, ISO13485
  • Experience in Injection moulding
  • Experience in assembly
  • Experience working with plastics
  • Experience leading lean and continuous improvement team, including documentation and reporting to management
  • Solid experience of managing CAPA’s and non-conformances
  • 8D experience is key
  • Six sigma, lean and continuous improvement
  • Experience in NPI and NPD
  • Experience with injection moulding or plastics is highly advantageous


Harris Lord is acting as a recruitment agency for this role



Contact: Adrian Hole

Keywords: CAPA, non-conformance, 8D, 13485, ISO 13485, plastic, injection moulding, lean, six sigma, engineer, quality, medical device

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