With the exception of independent contractors, applicants for this role will be engaged through Randstad company. When making this application your details will be automatically shared with Randstad company for registration with them, who may also contact you about other opportunities with other clients.
Quality Compliance Auditor (Freelance)
Project is closed
Posted Oct 6, 2021
Project ID: PHILJP00023994
(Oct 18, 2021 - Mar 31, 2022)
45 - 70 €/hr
Application Deadline: Oct 11, 2021 12:00 AM
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
+ Search all projects