Good designers are praised for their technique, great designers for their impact.
Over de functie
Manage the transition process to one QMS by means of Quality Planning
Implement Changes in the QMS related to:
-Philips level PQMS standards, procedures and End to End projects
-Regulations: EU MDR, ISO13485:2016, FDA QSR, Chinese FDA etc.
Keeping the Integrity of the QMS is an important requirement while implementing changes
CAPA: Act as CAPA owner for implementation of QMS Manager owned CAPA’s
Audits: Act as owner of resolution of findings of QMS Manager owned Audit findings
Improve way of working of the QMS team using LEAN methodology
Provides training for relevant QMS Management areas
Reports to the QMS Manager (team lead)
• Several years experience in a Minimum of three years of similar work experience in a medical device regulated environment
• Experience working in disciplined regulated industry and in applying automated technology.
• Experience validating activities
• Experience with business implementation projects, including being an active contributor on projects with scheduled deliverables.
• Demonstrated ability to understand and develop processes.
• Demonstrated ability to interact and communicate in English, including demonstrable writing, speaking, and comprehension skills;
• Ability to communicate across levels of the organization.
We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy.
We’ll offer interesting benefits and a market conform salary.
You’ll become member of the team of professionals who share your education, ambitions and your competencies.
This will enable you to interact with your colleagues from Yacht in your own technology language!
You’ll become a member of the yacht network, which stretches the high tech industry.
You will be challenged by your peers.
As a result you’ll be able to keep your knowledge and skills up-to-date!
Yacht is an Employer of Choice for many BSc, MSc, or PhD tech professionals who enjoy working in the famous Dutch High Tech industry.
Being part of the world wide Randstad Group, we operate as a strategic workforce partner for many international companies. We help them to build a competitive and agile workforce.
This extensive network of top level employers offers our Yacht employees a lot of challenging projects, dealing with cutting edge technologies.
Working for Yachts means you could work for respected tech companies like: ASML, Philips, TNO, Thermo Fisher, DAF, VDL, Océ and many others.
So would you like to work in the top of the global High Tech, join us.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer 06-13888330
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.