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olutions across the <a href="https://www.philips.com/b-dam/corporate/corporateblog/2016/Philips_Chronic_Disease_5.jpg" target="_blank">health continuum </a>. Our people experie
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Job Information

Philips Internal Auditor (L1 Philips Internal) in China - Home Based, China

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In this role, you have the opportunity to

Assure international regulatory and legal compliance of the Philips quality system(s) and company-wide compliance with Philips quality policies, quality objectives, and quality standards.

You are responsible for

  • Performing internal audits for multiple factories

  • Review of responses to audit findings for completeness and effectiveness

  • Participation in Quality & Regulatory initiatives as a cross functional contributor

  • A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.

  • Comprehensive knowledge of company products and services

  • Frequently interacts with supervisors, customers, and/or functional peer group managers.

  • Work often involves matters between functional areas, different company divisions or units, or customers and the company.

  • Experienced leader of cooperative efforts among members of a project team.

  • Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends

  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions

  • Acts as an advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.

You are a part of

Quality Operations Compliance team

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

  • Bachelor’s degree, or equivalent experience and 15 years’ experience in medical devices; 10+ years in an auditing function.

  • Qualified Lead Auditor according to Philips Q&R Internal Audit Process requirements. Current certification with a recognized accreditation body (i.e. RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA)

  • OR successful completion of a Lead Auditor Course.

  • 15+ years' experience in a regulated industry

  • 10+ years working in the area of quality management systems and/or regulatory affairs

  • Any applicable regulations/standards training (i.e. ISO 9001, ISO 13485, 21CFR820…).

  • Working knowledge of global governing regulations, requirements, and standards such as 21CFR Parts 803, 806, 820, 11; ISO 13485, ISO 9001, ISO 14971, European Medical Devices Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.

  • Strong CAPA Knowledge and experience.

  • Working knowledge of CFR ISO and ICH guidelines governing clinical research, and applying principles of 21 CFR Part 11 to clinical systems.

  • 3+ years of relevant experience in Clinical Quality Assurance, preferably with GCP experience.

In return, we offer you

A path towards your most rewarding career. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

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 .

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