Philips CAPA Facilitator in Haifa, Israel
Position Summary :
The CAPA Facilitator has the responsibility to manage and monitor CAPA activities, in full compliance with all applicable MD regulations, Philips Healthcare and IS policies and procedures.
Global facilitation of the CAPA process per all relevant procedures.
Review of Investigation or CAPA deliverables and clearance for Investigation/CAPA owners to proceed to the next CAPA process step.
Coordinator of the CAPA Review Board.
Generation of CAPA process metrics.
CAPA procedures, WI & templates creation in full compliance with all applicable MD regulations, Philips Healthcare and IS Policies and procedures.
Ensure alignment of CAPA activities, with other BU’s (i.e CT/NM, MR,).
Engage, drive and implement QMS harmonization initiatives driven by IS or PH for CAPA.
Analyze and report trends for all its products.
Be the center of knowledge for all the CAPA practices and the Trackwise tool.
Support and present CAPA during internal and external audits successfully.
Education/Skills and Experience Requirements :
Relevant academic degree, BSc – an advantage.
Knowledge of: ISO 13485, QSR 820 and PH adverse event reporting procedure.
Experience with CAPA.
Compliant handling experience – an advantage.
Good communication skills and personal relationships.
Good verbal and written communication skills with English fluency.
Ability to work effectively in a team oriented environment.