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- Worked as Certified Lead Auditor or Certified Quality Auditor
- *In-depth knowledge of FDA's 21 CFR 820, ISO 13485, ISO 14971, EU Medical Device
About Our Client
Our client is a world leader in health solutions. They offer a comprehensive range of medical devices, health technologies and much more. This technology company has the mission to improve people's life with their innovations.
The Innovation Site from our client is leading innovative product development for multiple business groups such as Personal Care or Health and Wellness.
As a strong leader you are capable of inspiring your stake holders as well as managing internal and external relations. It's a dynamic role in which you make a difference and can drive change. Of course you work intensively with a broad set of colleagues from different levels, expertise and geographic location. But in this role you're the single person responsible for the audits.
- Plan, coordinate, and execute QMS audits as Audit Manager, to assess the compliance and effectiveness of the overall QMS of the business IGT Systems being audited;
- Review responses to audit findings for completeness and effectiveness;
- You ensure your team is following the same audit processes in alignment with Philips Quality management system.
- Identify and share "Best Practices" within the business and business group.
- Participate in Quality & Regulatory initiatives as a cross functional contributor.
- Provide audit coaching/readiness training, and support and drive external audit.
- Building and managing relations with the Notified bodies and internal/external stakeholders;
- Manage the pool of part-time volunteer auditors in an inspiring and clear way.
The Successful Applicant
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job.
- Bachelor (or +) degree and Certified with a recognized Accreditation body (i.e. RAB-QSA / IRCA);
- Minimum 10 years of experience the medical device industry;
- Worked as Certified Lead Auditor or Certified Quality Auditor and/or Certified Bio-medical 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);
- Teaming up to excel - drive operational excellence when working with your audit teams and partners;
- Flexible to adapt to an ever changing environment;
- Good analytic skills and process improvement capabilities;
What's on Offer
Excellent hourly tariff