Quality Assurance 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

·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