Quality & Safety
Full time/Part time
In dienst van YER
Medical & Health
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.
- 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
- 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.