דרושים » אבטחת איכות QA » Operation Quality TL

DRS RADA is a global pioneer of radar systems for active military protection, counter-drone applications, critical infrastructure protection, and border surveillance. We are looking for an experienced QMS and Regulatory Compliance Director to join our team. Job Description: Overall responsibility for managing, maintaining, and continuously improving the organization’s Quality Management System (QMS), including certification processes, internal and external audits, regulatory activities, and compliance oversight, while ensuring alignment with organizational objectives, applicable standards, procedures, customer requirements, and relevant compliance obligations. Key Responsibilities:
* Lead and manage the organization’s Quality Management System (QMS) end-to-end across development, project management, operations, and production.
* Ensure the establishment, implementation, maintenance, and continuous improvement of quality processes, procedures, and controls in alignment with applicable standards and organizational requirements.
* Manage and develop the quality and regulatory team, providing professional leadership across quality, regulatory, and compliance activities.
* Oversee certification activities, internal and external audits, and the effective management of nonconformities, corrective actions, and preventive actions.
* Lead regulatory and compliance activities to ensure adherence to applicable requirements, customer expectations, and organizational commitments.
* Monitor performance through quality metrics and management reporting, and drive a culture of quality, accountability, and continuous improvement across the organization.

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