Quality Engineer to support Philips Research
General: Support Research Q&R manager in improving the Research QMS and managing CAPA.
KEY AREAS OF RESPONSIBILITIES
• Ensures compliant and effective Philips Research QMS is maintained in scope.
• Responsible for the transformation of all current QMS parts in scope towards the single PQMS structure.
• Responsible to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope.
• Manages (local) Q&R processes, including internal audit and CAPA, and ensures (local) process ownership for all activities under the PQMS governance in scope.
• Ensures Q&R requirements are effective in all processes in scope.
• Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.
• Maintains, enforces, and manages a compliant and effective QMS for the activities in scope.
• Manages the transition of the PQMS and manage its deployment.
• Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.
• Locally manages plan for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS.
• Ensures the addition and management of any local QMS documents in line with the evolution of the PQMS.
• Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary.
Must have items:
- min. 2 years Q&R role, preferably in a research environment.
- Experience in managing QMS document updates and system improvements.
- Knowledge of applicable QMS standards (ISO13485:2016, EU-MDR, 21 CFR820)
- Team player, pragmatic, pro-active, English speaking/reading/writing.
Nice to have items:
- Knowledge of PEPF/Aris