QA/QE - Post Market activities

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  • Dienstverband Fulltime
  • Vacaturenummer VAC-10012781
  • Locatie Veenpluis 4-6 Best Brabant NLD 5684 PC
  • Type overeenkomst Secondment via YER

Over deze vacature

We are looking for a QA/QE specialist in Post Market activities. This position welcomes you in 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.


Functie

o Quality Engineer

You are responsible for
o Formulate a project plan in accordance with the goals and timing
o Coordinate between different functions and ensure integrated plan will be executed.
o Support adoption of standard Philips processes in IGT-System QMS
o Create and drive adoption of QMS-changes requests for process within the scope of Q&R process holders
o Support Product Quality and Post Market teams with market data analysis; e.g. complaint trending, service parts monitoring etc

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
o Bachelor degree in technical field; preferably Mechanical, Electrical or Software Engineering.
o 2+ years experience in medical device industry.
o QMS management or (Quality-) project management experience
o Basic understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 820 and ISO13485
o Preferably experience with (post market) data analysis.
o Possess a high-level of self-motivation and getting things done mentality. Ability to effectively manage time, organize and prioritize work, multi-task across many assignments is necessary. Effective interpersonal, written and oral communication skills expected.
o Proficient in standard office computer tools: Microsoft Office, Word, Excel, Project and PowerPoint.
o Excellent English skills, written and speaking.

Bedrijf

With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision-making.

Aanbod

You will be employed by YER and seconded to Philips. We offer:

  • Good employee benefits
  • Excellent guidance from your consultant and YER's back office
  • Friendly atmosphere and open culture
  • Community/network with other technology professionals from a variety of multinationals
  • Events and master classes with interesting speakers and attractive companies

Profiel

  • 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, multitask 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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