QA Specialist

Eitan Medical is an international Medical Device company that develops and manufactures innovative medical equipment. Specifically, we develop infusion pumps and their related accessory products. Job Description: · supplier approval/disapproval including supplier maintenance and issuance of the Approved Supplier List. · Leading the SCARS process including SCAR initiation, SCAR follow up, Supplier investigation approval including root cause analysis and SCAR closure. · Leading the supplier audits process (including initial and surveillance audits) for critical suppliers, service centers, laboratories etc. by conducting on site / remote audits. Issuance and execution of the supplier audits plan including supplier audits follow up and supplier non-conformance follow up and response approval. • Support the execution of service agreements, quality agreements with suppliers and service centers. · Leading the supplier score card process, including trending. • 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 · Generate data and key quality trending information for use in periodic reviews like Quality Metric Reviews and Management Review for CAPA and supplier processes. • 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

Requirements: · 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. · Computer skills: 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 · Language skills: • English and Hebrew – fluent. · Personality: • Ability to evaluate, prioritize, organize, multitask and problem solving. • Ability to work in a team as well as independently