With the exception of independent contractors, applicants for this role will be engaged through Randstad company. When making this application your details will be automatically shared with Randstad company for registration with them, who may also contact you about other opportunities with other clients.


QA/QE - Post Market activities (Freelance)

Posted Jun 28, 2021
Project ID: PHILJP00023484
Best , Brabant
5 months
(Jul 15, 2021 - Dec 31, 2021)
40 hrs/week
Payrate range
45 - 67 €/hr

You are responsible for

  • Set-up and validate model to define required quality support for R&D projects.
  • Drive standardization of QMS processes owned by QA team; e.g. Product Hold process.
  • Coordination of Holds within scope of Product Hold process
  • Improvement of procedure for FDA Radiation safety Reporting for X-ray Systems

You are a part of

a fast growing and innovative Quality Assurance/Quality Engineering team, within an ever-changing environment - constantly striving for improvements and exceeding internal and external stakeholder expectations.

To succeed in this role, you should have the following skills and experience

  • Bachelor degree in technical field; preferably Mechanical, Electrical or Software Engineering.
  • 4+ years' experience in medical device industry; preferably in Post Market environment
  • Project Management experience
  • Experience with post market process like Field corrections and removals, Product Holds.
  • Preferably, experience with post market data analytics
  • High level understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, EU-MDR and ISO 14971
  • Possess a high-level of self-motivation and ability to work in a team. Ability to effectively manage time, organize and prioritize work, multi-task across many assignments is necessary. Effective interpersonal, written and oral communication skills expected.
  • Proficient in standard office computer tools: Microsoft Office, Word, Excel, Project and PowerPoint.
  • Excellent English skills, written and speaking.

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