Philips Quality Assurance Lead Auditor in Best, Netherlands
The Quality Assurance Lead Auditor (QA lead auditor) is responsible for auditing Philips Digital Pathology Solutions and its suppliers to ensure compliance with Quality System and regulatory requirements. As lead auditor you will also partake in initial assessment of suppliers as part of the selection process.
At Philips Digital Pathology Solutions the QA lead auditor works closely with supply chain, service and procurement and reports to QA manager.
This role requires extensive travel and an ability to work independently without direct supervision as well as in a team environment
Plan, coordinate, and execution of all audit activities to assess the compliance and effectiveness of the overall QMS.
Ensures suitable responses to audit non-conformances are provided by auditees within agreed upon timeframe.
Reviews responses to audit findings for completeness and effectiveness.
Identifies and shares “Best Practices” within Philips.
Provides support ensuring external audit readiness and during external audits.
Identifies at risk areas in need of compliance support through the monitoring of actions and the assessment of compliance data, and assists these in addressing compliance deficiencies.
Participates in Quality & Regulatory initiatives as a cross functional contributor.
Provide support during supplier assessments and audits.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
We are looking for
Bachelor’s degree or equivalent experience
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 or successful completion of a recognized Lead Auditor course.
Minimum 2 years active lead auditing with demonstrated expertise in a highly regulated environment. Knowledge of subjects mentioned below but not limited to:
ISO Standards (i.e., 13485, 14971, 14001)
US, EU & International Medical Device Regulations (e.g., 21 CFR Parts 801, 803, 806, 812, 820, MDD)
Agile development methodologies
Demonstrated CAPA knowledge and experience.
Demonstrated experience with safety and security risk management.
Ability to set priorities, work independently without direct supervision as well as in a team environment.
Ability to change the thinking of, or gain acceptance from, others in sensitive situations.
Excellent communication skills.
Pragmatic hands-on mentality.
Conscientious and precise delivery of work even when under pressure
After a pre-selection process based on your CV, you will be invited for face-to-face business interviews.