Senior Q&R Compliance Auditor

As a Senior Q&R Compliance Auditor you:
•Provide support to Philips Healthcare internal audit program as a lead auditor. Plan, conduct and report internal audits according to predetermined schedule;
•Assist in the planning and scheduling of the internal audit program;
•Actively contribute to the development of an effective operating mechanism for the current internal audit program, facilitating effective and timely communication of audit results, trending, and data mining;
•Prepare and present summaries of internal audit results to various levels of Philips Healthcare management;
•Provide training regarding quality system standards and regulations;
•Facilitate effective corrective/preventive actions. Ensure audit non-conformances are addressed in a timely manner;
•Lead and/or participate in quality system change and improvement activities; •Provide early indication of future changes in medical device regulations and/or quality systems standards;
•Actively promote a quality and regulatory compliance culture within Philips Healthcare by creating an environment, in which open discussion and reporting of concerns is promoted and encouraged (lead by example!).

We simplify healthcare by focusing on the people in the care cycle - patients and care providers. Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system. Philips delivers advanced solutions for both health professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in hospital or at home. Some product highlights: 256-slice Brilliance iCT scanner, Integrated cath lab, Avalon FM 20 & FM 30 fetal monitors, Ambient Experience MR and CT systems, Philips Lifeline's personal emergency alert service.

The Philips Healthcare Q&R Audit Department is responsible for conducting worldwide, internal audits for compliance to medical device quality system regulations and/or standards.

To be successful in this role, your profile includes:
•Bachelor degree in Engineering or similar plus a minimum of 10 years experience in a medical device or regulated industry or minimal 15 years of experience as a quality professional in a medical device or regulated industry;
•Lead Auditor credentials for ISO 13485 and ISO 14001 quality system requirements; or Certified Quality Auditor (CQE);
•In-depth knowledge of FDA's GMP requirements of 21 CFR 820;
•In-depth knowledge or experience of medical device regulatory requirements related to Software Validation (Product Design), Risk Management (ISO 14971), Medical devices Reports of Corrections and Removals (21 CFR 806), Medical Device Reporting (21 CFR 803), EU Medical Device Directive (93/42/EEC), Japan's Pharmaceutical Affairs Law (Ministerial Ordinance NO. 169), Canadian Medical Device Conformity Assessment System (SOR/98-282), Experience interfacing with External Regulatory Agencies (e.g. FDA, Notified Bodies);
•Current experience conducting quality system internal audits;
•Work independently in a fast-paced environment with little supervision;
•Open to other's ideas and work collaboratively across functions;
•Ability and willingness to travel intensively.

Any location in Europe is suitable for this position If you recognize yourself in this profile and would like to take this challenge, we invite you to apply!

Martijn Kempen
+31 (0)6 211 357 87