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.

Responsibilities :

  • 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.