NL - Quality & Regulatory

Posted on Oct 4, 2019 by Randstad Multilingual Recruitment Banen

Eindhoven, Netherlands
Health Care
Immediate Start
Annual Salary

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 (ISO, EU MDR, 21 CFR820)
Team player, pragmatic, pro active, English speaking reading writing.

Nice to have items
Knowledge of PEPF Aris

Reference: 766464550

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