Quality Engineer


Premium Job From Candidate Source Ltd

Recruiter

Candidate Source Ltd

Listed on

5th April 2019

Location

London

Salary/Rate

£50000 - £60000

Type

Permanent

Start Date

ASAP

This job has now expired please search on the home page to find live IT Jobs.

A specialist, UK based Medical Device / Software company with a market leading product sold and installed globally is seeking a Quality Engineer to join its team based in London.

The company was established over 10 years ago, seeing significant growth over the past 5 years it is offering a stable platform with excellent training benefits for personal employee development. The company continues to invest in R&D and expansion, supporting this, they have created this Engineer position for you to join them in its London facility.

Your duties will include:
Reporting to the Quality & Regulatory Affairs Director and the Manager.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 design change control, maintaining the QMS and assist with CAPAs and raising non-conformance.  To be successful you will have the following skills and experience:
Software development environment - medical devices experience or experience within a regulated environment such as pharmaceutical, defence, aerospace, automotive, comms or related.Ideally, extensive experience within a quality focussed / 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. In return, the Engineer will receive a salary of Circa £50,000 - £60,000 per annum (candidates seeking more or less will also be considered) plus an excellent benefits package including bonus, healthcare, training bursary and pension.

This is an excellent opportunity for someone with software development experience to join an established and growing medical device specialist with a market leading product line - offering a broad role with autonomy within a dynamic environment as well as an excellent salary and benefits package.

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