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