Job Description:
Support the execution of service agreements, quality agreements with suppliers and service centers.
Serve as Eitan Medicals CAPA Coordinator and Subject Matter Expert
Responsible and accountable for CAPA ownership, timely execution, and effectiveness of CAPA’s. This includes creation, collaboration with functional teams on Problem Statement writing/Scope identification/Risk Assessment/Containment/Correction/CAPA plans/Verification of local and global compliance to CAPA procedures to ensure timely effective closure of CAPAs
Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.
Write, update, release, and sign quality documentation within the Quality management system
Direct manager: QA Compliance Manager
·Education:
o Practical Engineer/ B.Sc. in Quality/ Biomedical/ Biotechnology or similar or CQM / CQE.
Job skills:
3- 5 years of relevant experience.
Good knowledge of ISO 9001, ISO 13485 and international standards.
o Knowledge and experience with quality processes.
o Experience in the field of Medical Devices - an advantage.
o Knowledge and experience in quality processes
o Auditor certificate - an advantage.
o Good knowledge of MS-Office tools (Excel, Word, PP).
o Acquaintance with E-Document management systems.
o Knowledge of statistical based computer programs such as Excel and/or Minitab
English and Hebrew – fluent.
Ability to evaluate, prioritize, organize, multitask and problem solving.
Ability to work in a team as well as independently
