QA Coordinator

  • Jobdomein Quality & Safety
  • Full time/Part time Fulltime
  • Vacaturenummer VAC-10000966
  • Locatie Zaventem
  • Dienstverband In dienst van YER
  • Branche/sector Medical & Health

Samenvatting

YER is looking for a QA coordinator for a project in Zaventem.

Over de functie

  • Assisting the QA Specialist to ensure that all departments are compliant with our internal quality requirements.
  • Assisting the QA Specialist to maintain the Quality Management System to ensure that the Company is compliant with our quality guidelines.
  • Maintaining all quality documents and records up to date.
  • Assisting the QA Specialist with the document managing control (change order process).
  • Assisting the QA Specialist to act as a lead on the quality matters in the Company by implementing the Philips Volcano Quality System according to the European and International guidelines, which maintain our EN/ISO and other global regulatory requirements into our corporate quality manual and SOPs.
  • Assisting the QA Specialist by maintaining the TEDS (Electronic Training Management System).
  • Ensuring that all processes and records are in full compliance with the implemented procedures by reporting on the performance of the quality system and creating basis for improvements.
  • Facilitating CAPAs and NCRs where necessary.
  • • Supporting the Operations Team with the implementation of the physical distribution, the logistic operations and the field services procedures.

Over het bedrijf

A technical client.

Wat wij bieden

You will be employed by YER for a project sourcing at our client.

We offer

  • Good employee benefits
  • Excellent guidance from your consultants and YER’s Back office
  • Friendly atmosphere and open culture
  • Community/network with other professionals from a variety of multinationals
  • Events and master classes with interesting speakers and attractive companies
  • There is also the possibility of being hired as a freelancer

Functie eisen

  • Bachelor’s degree with at least +2 years of experience in a highly-regulated, Quality department (not necessarily distribution)
  • Proficient in English, both written and spoken, local language is an advantage
  • Basic knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.)
  • Previous experience with CAPA - their investigation and conclusion
  • A good communicator on different organizational levels
  • Have an good understanding of quality philosophies, principles, systems, methods, tools, standards
  • Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.