Quality Engineer (Product Development)

Cambridge, UK

The Purpose of the Post:

Owlstone is seeking a Product Development Quality Engineer to lead delivery of future product developments for commercialisation in Europe, including some CE marked medical devices.

Key Responsibilities and Duties:

  • Provide Quality Engineering representation on Product Development Teams
  • Support design control activities for new product development efforts
  • Assist in the writing, review and approval of verification and validation test plans and reports
  • Develop process validation requirements (IQ, OQ, PQ) and equipment qualifications as part of the design transfer activities
  • Support completion of Essential Requirements Checklists for new medical devices
  • Support Project Managers with Design Reviews, Risk Management and Hazards Analysis
  • Ensure traceability throughout all Technical File documentation
  • Conduct and lead process/design/procedural failure mode effects and analysis
  • Conduct evaluations and audits of new suppliers as part of the new product development project teams, and help to create supplier agreements where required
  • Ensure compliance to regulatory requirements including as appropriate the Medical Devices Directive, ISO 9001:2015
  • Apply ISO 14971 to Risk Analysis where required
  • Ensure product development compliance with the Quality Management System
  • Lead design transfer to manufacturing in conjunction with the NPI/Manufacturing Engineer
  • Assist with external audits to achieve and maintain ISO accreditation
  • Be part of the Internal Audit team
  • Support the QMS as required by the QA Manager
  • Provide a positive example and actively promote compliance to all standards

Essential Experience and skills

  • Educated to degree level
  • Proven experience in product development and quality engineering related activities, preferably in a medical device environment
  • Experience of regulatory requirements including the Medical Devices Directive, Machinery Directive or Low Voltage Directive
  • Able to author documents for inclusion in the Device Technical File
  • Ability to work on cross functional teams
  • Ability to demonstrate a self-motivated and highly organised approach to work
  • Experience of working with minimal supervision in a fast paced, multiple disciplinary environment
  • Good written and verbal communication skills
  • Ability to create and provide training

About Owlstone:

Owlstone Medical has developed a breathalyzer for disease www.owlstonemedical.com.

Every time you breathe out there are hundreds of chemicals on your breath - some are tell-tale markers of disease that our microchip chemical sensor technology is able to detect.

Our vision is to change the way we currently diagnose and monitor serious disease; we aim to become the global leader in the non-invasive detection of cancer, infectious disease and inflammatory disease. The key is detecting diseases earlier, when treatments are more effective, where more lives can be saved. There is no better example than cancer, where if detected early the chances of survival can be as good at 95% but at late stage drop to about 5% - unfortunately there are still far too many people detected at late stage.

The Owlstone group also commercialises a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defence.

Owlstone is an equal opportunity employer and we will consider all qualified applicants for employment without discrimination on any characteristic protected by law including but not exhaustive to; grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status.

Due to the nature of our business, all employment is subject to satisfactory references being obtained and attainment of a Baseline Personnel Security Standard (BPSS) check.

We offer a relaxed, friendly, flexible and international working environment with a great team-spirit. You will be rewarded with a competitive salary package that includes future share options and your work will have a clear impact on people’s lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone may be the place for you.

To apply, please submit your CV and a covering letter explaining why you want to work with us and how you fit the role to https://app.smartsheet.com/b/form/3053b67ea0b241a5b7e4cc5100de936f


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