*** Exclusive vacancy *** Quality Engineer - North London

£45,000 to £55,000 per annum plus 20% bonus, healthcare and pension - Quality Engineer
Ref: 2 Date Posted: Thursday 12 Sep 2019
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*** Exclusive vacancy to Indo Professionals ***
 
An excellent opportunity for a Quality Engineer / Snr QE with software development experience to join an established and growing medical device specialist with a market leading product line – our client offers a broad role with autonomy within a dynamic environment as well as an excellent salary and benefit package.
 
Our client is a specialist, UK based Medical Device / Software company with a market leading product sold and installed globally.
 
Established over 10 years ago, they have seen significant growth over the past 5 years and offer a stable platform with excellent training benefits for personal employee development.
 
They continue to invest in R&D and expansion, supporting this, they have created a new position for a Quality Engineer / Senior Quality Engineer to join them in their London facility.
  
As a Quality Engineer your role will involve:
 
  • Reporting to the Quality Manager & Quality & Regulatory Affairs Director
  • Supporting the R&D teams across three sites and will be responsible for ensuring all product development activities from design and test to design project closure are fully compliant.
  • Regular interaction with the product development and test teams as well as management and SCRUM Masters.
  • Provision of independent quality review within medical device / software product development projects
  • Attendance to development meetings and design reviews
  • Reviewing and approving design specifications software FMEAs, test reports and plans and architecture documents
  • Assist with or manage internal audits and supplier audits
  • Performing Computer Systems Validation (CSV)
  • Assist with CAPAs and raising non-conformance
  • Assist with design change control
  • Assist with maintaining the QMS
 
The ideal candidate will have the following experience:
 
  • Software development environment – medical devices experience or experience within a regulated environment such as pharmaceutical, defence, aerospace, automotive, comms or related
  • Ideally 5 or more years’ experience within a quality focused / product development environment, medical devices experience preferred, otherwise experience within a highly regulated environment
  • Ideally degree level educated within an engineering or scientific discipline
  • Agile development methodology
  • Experience of IEC 62304 highly advantageous
  • Understanding of risk management, ideally working to ISO 14971
  • Experience of working in a quality design and engineering environment / matrix environment
  • Experience of working with electronic / programmable devices
  • Experience and training in computer systems validation preferred or understanding of IQ OQ PQ principles