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Quality Engineer CAPA Medical Devices

TEC PARTNERS LIMITED
Job LocationFarnborough
EducationNot Mentioned
Salary£45,000 - £50,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Product Quality Engineer (CAPA) - North Hampshire - Medical DevicesOur client is a rapidly growing medical devices company in North Hampshire that develops innovative electronics medical devices for a range of critical-care applications. I am looking for an experienced Supplier Quality Engineer, ideally with exposure in Medical Devices that is looking to join a progressive, forward thinking company.Product Quality Engineer Responsibilities:

  • Ensuring that appropriate quality plans include all stages of the product life cycle
  • Validate key design inputs like: usability, reliability, performance & manufacturability
  • Provide oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product lifecycle
  • Perform analysis on product quality performance and post-market product quality
  • Leading quality related problem solving and root cause analysis during both design and manufacturing
  • Act as a point of contact responsible to ensure that software and hardware design meets quality and compliance standards for every part of the product lifecycle
  • Quality Monitoring for the entire QMS, and the elements applicable through the product lifecycle
  • Work effectively with all levels of management to ensure plans can be supported and that costs/resources needed to implement the plan are available.
    • Product Quality Engineer Profile:
  • Bachelors degree in engineering or equivalent technical experience
  • Demonstrable experience in Quality Engineering and CAPA processes in a medical device or highly regulated industry
  • Working knowledge of medical device regulations (21CFR), MDD/MDR, other regulations and standards including ISO14971 & IEC 60601
  • Prior knowledge of the new product design and development process in a regulated environment; ideally medical devices
  • Able to understand and analyse complex problems, which may including software and hardware design issues
  • Strong Project Management skills, including ability to project manage all activities, ability to prioritize and time manage effectively
  • Excellent written and verbal communication skills
  • Must be able to travel locally and internationally / full drivers license
  • Lead auditor training to ISO13485:2016 (beneficial)
  • Able to read, understand/ interpret Engineering drawings
  • Able to read, understand/ interpret Engineering drawings and ability to use basic measurement hand tools, e.g. vernier gauges, height gauges, torque drivers
    • This is an excellent role within a market-leading business, and as such my client offers a highly competitive package with great benefits.If youre interested in this position, then dont hesitate to get in touch with Jamie @ TEC Partners directly.

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