Senior Compliance Auditor

Job TitleSenior Compliance Auditor

Job Description

In this role, you have the opportunity to

Perform timely, detailed, and independent internal Good Clinical Practices (GCP) and Quality Management System (QMS) audits to assess regulatory compliance to applicable local and international regulations/standards and Philips Healthcare requirements.

You are responsible for

  • Planning, coordinating, and executing QMS audits as Lead Auditor, to assess the compliance and effectiveness of the overall QMS of the Philips Healthcare organizational unit(s) being audited;
  • Reviewing responses to audit findings for completeness and effectiveness;
  • Participating in PH Quality & Regulatory initiatives as a cross functional contributor;
  • Providing audit coaching/readiness training, and support for external audits;
  • Preparing and presenting timely summaries of internal audit results to various levels of Philips Healthcare management;
  • Facilitating effective corrective/preventive actions; ensuring audit nonconformances are addressed in a timely manner;
  • Actively promoting 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!)

You are a part of

Internal Audit & Compliance is part of the Quality & Regulatory organization. Its mission is to proactively identify, communicate, and assure the mitigation of quality and regulatory compliance risks in order to help protect Philips' patients, customers, business, and brand. The Compliance Audit team helps to build self-confidence in the organization through the execution of audits and identifying risks to the Philips organization.

To succeed in this role, you should have the following skills and experience

  • BS/BA plus a minimum of 10 years of experience in a medical device or regulated industry;
  • Certified Lead Auditor; or ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA); or Certification with a recognized Accreditation body (i.e. RAB-QSA / IRCA);
  • In-depth knowledge of FDA's 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282);
  • In-depth knowledge or experience of medical device regulatory requirements related to: Medical devices Reports of Corrections and Removals (21 CFR 806), Medical Device Reporting (21 CFR 803) and Risk Management (ISO 14971);
  • Working knowledge of appropriate global medical device regulations, standards, and requirements including: ISO 9001, MHLW Ord.169, ANVISA, IEC 62304, IEC 60601-1;
  • Government/regulatory-body Quality System auditing/inspection experience preferred (i.e., former FDA);
  • Fluent in English and Chinese;
  • Ability to analyze information and come to conclusions based on presented data.

In return, we offer you

The opportunity to travel the world and gain truly diverse experiences. In addition, you are going to be home-based but at the same time be a part of an amazing team. Furthermore, we offer you a great compensation package, 25 days off with the opportunity to purchase 20 extra per year, as well as personal and professional growth opportunities.

Why should you join Philips?

Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

Contact

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