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Job Details

Consultant Name : Adam Shortland
Job : Quality Assurance Engineer / Senior QA Engineer
Job Ref : 11237
Location : Cambridge
Salary : 35000-60000
Description :

We are looking for an experienced Quality Assurance Engineer to join a multidisciplinary team within a highly professional, technical R&D consultancy based just outside Cambridge. You will be responsible for the development, evaluation and auditing of Design History Files (DHF) internally as well as ensuring suppliers and sub contract manufacturers are operating to the highest of professional standards.

Job requirements:

  • Good degree ( BSc, BEng, MEng etc) in Mechanical Engineering, Production Engineering, Electronics or similar Engineering or Physical Sciences.
  • Quality Management experience - preferably in the medical devices, healthcare and/or pharmaceutical manufacturing area.
  • Experience in FDA 21 CFR Parts 820, 211 and 210 quality system requirements.
  • Experience in ISO 13485 quality management system requirements
  • Experience in ISO 14971 - Application of Risk Management to Medical Devices
  • Risk Management Files; Plans, Hazard Assessments, Design FMEA, Process FMEA
  • Good knowledge of Design History File Documentation and procedures : Plans, Design Inputs, Verification, Validation, Design Reviews, Design Outputs
  • Change Management, Discrepancy Management, Complaint Handling and CAPA
  • Experience of internal/external QA/QC auditing
  • Ability to write factual reports and to communicate findings to clients at all levels
  • Ability to lead projects, taking responsibility for quality, time and profit
  • Bright, conscientious and creative with an ability to demonstrate a hobby or interest with a practical or technical relevance.

In return:

It is a cracking company to work for -a variety of fast moving, high tech projects and the chance to work with some of the brightest Engineers & Scientists in the UK. The company also puts a high degree of emphasis on personal development and invests heavily in ongoing training and professional development.

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