The position reports to the Head of Q&R for the Connected Care Informatics Business
- Maintains a robust and efficient QMS and behavior that will be accepted by our customers and regulators as best in class.
- Represent the business during any audit, internal or external.
- Drive compliance across all functions of the business and ensure preparedness for any audits. Audit findings, to reinforce compliance or remedial action on any unsatisfactory findings.
- Implements appropriate activities to ensure efficiency with complaint handling, corrective and preventive action, and the internal audit program.
- Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
- Recommending and implementing changes to methods.
- Bachelor's degree (Science, Engineering or similar technical field) required, Master's degree in business, management or quality strongly preferred
- Minimum 10 to 12 years working experience of which a couple of years progressive management experience in a responsible Quality Assurance/Regulatory Affairs role (required)
- Experience in Quality Systems is required and experience in Regulatory Affairs is an advantage. Good understanding of ISO13485, EUMDR standards
- Experience in Software development and products is required
- Medical Device experience is required.
- Strong partner leadership skills
- Experience with FDA and other world-wide standards and regulations is preferred
- Achievement oriented and customer focused
- Would help if there is knowledge of Philips PEPF
- Experience of facing external audits for 13485, EUMDR, MDSAP etc
- Knowledge of SW related standards and working experience in QA function of a SW product