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 timely, detailed, and independent internal quality management system (QMS), product-focused, and/or clinical study audits. You will be qualified and capable to act as both an Auditor and Lead Auditor, as the Audit Program Lead and specific audit scope requires.
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.
Strong influence on business magnitude > 100M.
You are a part of
A small team of Quality & Regulatory experts based in different Philips locations. You will report to the Director Quality Operations Compliance. This position will be homebased in the Netherlands.
To succeed in this role, you should have the following skills and experience
Bachelors degree with a min. of 15+ years of industry experience and 5-7 years in auditing.
Qualified Lead Auditor; 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.
Auditing experience in the medical devices industry is a must.
1+ 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.
Relevant experience in Clinical Quality Assurance, preferably with GCP experience.
In return, we offer you
You will join an innovative and meaningful environment with great opportunities for you to explore.
Why should you join Philips?
Working at Philips is more than a job. Its 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 its 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.
If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it.
If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to email@example.com. (Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)