Quality Compliance Auditor (Freelance)
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. Responsible to perform timely, detailed, and independent internal quality management system (QMS), product-focused, and/or clinical audits to assess regulatory compliance to applicable local and
international regulations/standards and Philips requirements
- Plan, coordinate, and execute internal QMS and/or product-focused audits to assess the compliance and effectiveness of the overall QMS of the organizational unit(s) under audit.
- Plan, coordinate, and execute clinical audits to assess clinical study compliance with Good Clinical Practice (GCP), regulatory standards, and study procedures.
- Review responses to audit findings for completeness and effectiveness.
To succeed in this role, you should have the following skills and experience
- Bachelor's degree in an engineering or scientific discipline, or equivalent experience
- Working knowledge of appropriate global medical device regulations and standards
- 3+ years experience in a regulated industry (medical device, IVD)
- 3+ year working in the area of quality management systems and/or regulatory affairs
- Qualified as Lead Auditor with sufficient audit experience
- Strong personal skills demonstrating structured and self-organized way of working
- Ability to communicate effectively both orally and in writing with business leads, subject matter experts and other functional areas.
- Strong analytical and process focused thinking skills
- Ability to work in a virtual team and within a cross functional global organization
- Demonstrate Philips behaviours