Quality Engineer

Posted Oct 3, 2019
Project ID: PHILJP00020697
Eindhoven , Noord Brabant
2 months (Oct 14, 2019 - Dec 31, 2019)
40 hrs/week
Payrate range
Quality Engineer to support Philips Research

General: Support Research Q&R manager in improving the Research QMS and managing CAPA.

•   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
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