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