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Quality Engineer - Medical Devices

TEC PARTNERS LIMITED
Job LocationNorfolk
EducationNot Mentioned
Salary40,000 - 50,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

TEC Partners are pleased to be working with a market leading company who design, develop and manufacture drug delivery devices across the globe. They are leading the way in drug delivery innovation, driven by customer and patent demand, offering the potentialto create new treatments and opportunities.Quality Engineer - Medical Devices Role:As an integral part of the quality engineering team, you will support and deliver a range of Quality Engineering activities with a focus on NPI programmes. You shall support and take ownership for the requirements through the design and development processworking closely with internal departments, customers and suppliers/other companies to understand, plan and execute the design and development stages. Another key part of this role is to contribute to the wider QE team and provide input and support during theproduct lifecycle with the ability to provide general cover and input on decisions with the QE team.Quality Engineer - Medical Devices Responsibilities:

  • Identify, define and deliver all QE deliverables to ensure product quality and compliance, within agreed cost and timelines against standards such as ISO 13485 and 21 CFR part 820
  • Engage/develop relationships with internal/external customers to provide regular updates on programme stages associated with quality providing specialist technical advice where required
  • Ensure Risk Management and Validation activities are completed and updated effectively. Conduct independent document reviews and approvals to ensure compliance with input documents including Usability/Human Factors, ISO 10993 testing, ISO 14971, IEC 62366,reliability requirements and Essential Performance Requirements (EPRs)
  • Support internal and external teams with QE activities associated with transfer into commercial operations and commercial validation. Generation of documentation (as either Author, reviewer, approver) that ensure programme/product is compliant through theNPI stages of development. Including documentation required for the Design History File and Regulatory submissions.
  • Review and agree the release of NPI products based on their usage (development testing, clinical trials, verification, validation etc.), ensuring they are according to the customer requirements and are compliant to the applicable regulations
Quality Engineer - Medical Devices Requirements:
  • A minimum of 3-5 years working in Medical Device, IVD and/or combination product industry ideally focused on NPI/programme support
  • Good working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, ISO 10993, GMP, European Medical Device Regulation, QSIT
  • Ability to manage changing priorities adapting to multiple projects at the same time
  • Exposure to Six Sigma and statistical tools desirable not essential
  • Knowledge and application of design control, risk management requirements for medical device/combination products
Being an integral part of this ever growing, successful medical device company, you are rewarded with private health care, competitive salary and learning development opportunities.If this role sounds of interest, please apply at your earliest convenience with an up to date CV.

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