Compliance Auditor - Quality Management Systems
As Compliance Auditor you are part of our Quality & Regulatory Affairs organization. It concerns a highly accountable role in which you are managing the internal Quality Management System audits within the Philips organization.
- Single point of contact managing the relationship between Philips Personal Health BG and the Notified Body
- Liasion between Personal Health BGS and the Notified Body
- Plan, coordinate, and execute QMS audits as Lead Auditor, to assess the compliance and effectiveness of the One BMS of the Philips Personal Health organizational unit(s) being audit;
- Compile and report metric for the internal audit program.
- Review responses to audit findings for completeness and effectiveness;
- Manage our pool of part-time volunteer auditors in an inspiring and clear way.
We are looking for
- Bachelor (or +) degree and Certified with a recognized Accreditation body (i.e. RAB-QSA / IRCA);
- Minimum 5 years of experience the medical device industry;
- Worked as Certified Lead Auditor or Certified Quality Auditor and/or Certified Biomedical Auditor ;
- In-depth knowledge of FDA’s 21 CFR 820, ISO 13485, ISO 14971, EU Medical Device Directive (93/42/EEC), JPAL, ANVISA, Canadian Medical Devices Regulation (SOR/98-282);
- Government/regulatory-body Quality System auditing/inspection experience preferred (i.e., former FDA);
- Good knowledge and understanding processes in the medical device industry;
- Teaming up to excel – drive operational excellence when working with your audit teams and partners;
- Accurate, able to evaluate risks and able to take ownership;
- Flexible to adapt to an ever changing environment;
- Good analytical skills and process improvement capabilities;
- Excellent communication skills in English;
- High energy, strong sense of urgency, self-motivated and results-oriented;
- Positive mindset, able to energize others;
- Willingness to travel worldwide. (an average of 25%)
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 a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals.
Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects for our clients in the Dutch “Brainport” Eindhoven region, mainly on projects at our clients’ Research & Development departments. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology. To give you an example of our portfolio: ASML, Philips Healthcare, Philips Lighting, Philips Research, TNO, FEI company, DAF, VDL ETG, Océ and many others.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer +31 0655724609
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.