Sr. QA Specialist

Position: Sr. 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.
• Manage all training activities within the organization (scheduling, follow ups, etc.)
• Reviewing employee trainings records to ensure that employees have completed all required training prior to performing their jobs.
• Monitoring and reporting on all training activities.
• Responsible for the annual training plan creation and execution.
  
  

• 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
• 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