QA Specialist

Description

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