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 .