דרושים » רפואה ופארמה » QMS and Regulatory Compliance Director

We are a global pioneer of RADAR systems for active military protection, counter-drone applications, critical infrastructure protection, and border surveillance. We are looking for a motivated and experienced Supplier Quality Engineer to join our team! As a Supplier Quality Engineer, you will be responsible for managing supplier programs for manufacturing and ensuring that quality programs follow regulatory requirements. Supplier Quality Engineer duties and responsibilities
* Driving supplier quality performance, including new product development and product quality improvement
* Providing leadership and management for the supplier quality department
* Ensuring the supplier meets all regulatory and company requirements.
* Performing quality system audits
* Establishing quality control objectives & Maintaining supplier quality records
* Promoting initiatives to improve quality.

Join us as a Senior Operation Quality TL, where you will lead quality initiatives to ensure operational excellence in our products and services.

Responsibilites
Lead and manage in‑process and final QC inspection activities, including supervision and professional development of QC staff.
Support and maintain the Quality Management System (QMS) in accordance with company and regulatory requirements.
Responsible for calibration management of ORBIT equipment.
Manage employee certification processes (internal and external) and develop annual training plans.
Lead and support continuous improvement initiatives in collaboration with Operations teams.
Review and approve ECO / MCO / ATP / ATR / production documentation, and waivers related to R&D and Engineering.
Lead customer complaint investigations using structured methodologies (8D, RCCA, etc.).
Plan and perform internal quality audits.
Support and participate in external quality audits and certifications (customers, FAA, CAAI, SII, etc.).
Perform and approve First Article Inspections (FAI) in accordance with AS9102.
Monitor failures and ensure effective follow‑up of corrective and preventive actions (CAPA).
Analyze quality trends and performance indicators (Quality Yield, KPIs).
Manage RMA processes and perform quarterly quality data analysis for QBRs.
Prepare Quality Plans (QP) and Quality Improvement Plans (QIP).

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

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 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