QMS Manager (Freelance)
Manage the transition process to one QMS by means of Quality Planning
Implement Changes in the QMS related to:
Philips level PEPF standards, procedures and End to End projects
Regulations: EU MDR, ISO13485:2016, FDA QSR, Chinese FDA etc.
Keeping the Integrity of the QMS is an important requirement while implementing changes
Improve way of working of the QMS team using LEAN methodology
Provides training for relevant QMS Management areas
Reports to the Quality Program Manager
- Several years experience in a Minimum of three years of similar work experience in a medical device regulated environment
- Experience working in disciplined regulated industry and in applying automated technology.
- Experience with business implementation projects, including being an active contributor on projects with scheduled deliverables.
- Demonstrated ability to understand and develop processes.
- Demonstrated ability to interact and communicate in English, including demonstrable writing, speaking, and comprehension skills;
- Ability to communicate across levels of the organization.
- Great Office tools knowledge