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our company 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  CAPA Coordinator and Subject Matter Expert
* Responsible and accountable for CAPA ownership, timely execution, and effectiveness of CAPAs. 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

We are a Sisram Medical company, is a global leader in medical-aesthetic technologies, with over 25 years of experience in energy-based devices (EBD). Over the years, we have evolved into an integrated aesthetic and wellness ecosystem that combines medical devices, injectables, diagnostics, and personalized skincare. The company operates in a dynamic, innovation-driven environment, merging advanced technology with deep clinical understanding to create holistic solutions for aesthetic clinics. Our headquarters are in Caesarea, Israel, with business operations in more than 100 countries worldwide.
We are seeking a mechanical engineer to join the R&D department of an aesthetic medical device company. In this position you will be creating detailed designs of multidisciplinary projects while working on multiple tasks simultaneously. You will be closely working with other teams within the R&D department (software, electronics, physics, NPI) and the engineering team. You will work with subcontractors in Israel and abroad and validate the supplied parts/assemblies.

Review of Contract ,Customer SOW and SPEC requirements to ensure compliance of design and production.
Approve gates review at R&D
PLCM (Project Life Cycle Management) - process control, full partnership in project management during the development, testing, production, customer delivery and customer support phases throughout the product life
Identifying regulatory Gaps in new and carrent projects
Perform Internal and External Audits
QA presence in R&D process (capacity) and ability to prevent errors in design
Follow up after R&D corrective and preventive actions and Improvement Plans
Transfer products from development to NPI and serial production (QA activities)
Review and approval ECO / MCO / ATP/ATR, Waiver relate to R&D , ENG
Writing QA procedures
FRACAS Management
Quality Assurance Program Plan (QAPP) and the Quality Allocation Tasks for the program.
Customer complince - relate to NPI , Pre production , design errors
Perform Quarterly data analysis for QBR

Design of new, and support of existing airborne, marine and stationary pedestals to meet with environmental requirements.
Produce designs meeting performance, cost and manufacturability goals
Create fabrication and assembly drawings as well as related documentation
Support prototype assembly, assist in integration and test

Design of new, and support of existing airborne, marine and stationary pedestals to meet with environmental requirements.
Produce designs meeting performance, cost and manufacturability goals
Create fabrication and assembly drawings as well as related documentation
Support prototype assembly, assist in integration and test