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
  
  

• Education:
• 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.
• Knowledge and experience with quality processes.
• Experience in the field of Medical Devices - an advantage.
• Knowledge and experience in quality processes
• Auditor certificate - an advantage.
• Computer skills:
• Good knowledge of MS-Office tools (Excel, Word, PP).
• Acquaintance with E-Document management systems.
• 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