לוח משרות דרושים מנהל איכות | מנהל QA משרה מלאה, לחיפוש זה נמצאו 82 משרות

As a Quality Program Manager, you will play a critical role in the integration of CathWorks quality systems and processes into our global quality framework. Based in Kfar Saba, this onsite position is responsible for ensuring the seamless alignment of design controls, CAPA, complaints handling, software development lifecycle, and regulatory compliance processes. Working across multiple functions, you will help drive quality excellence, regulatory readiness, risk mitigation, and process harmonization while supporting the successful integration of innovative digital health technologies into the portfolio.
Responsibilities may include the following and other duties may be assigned:

Work with the Integration Lead on integration planning for quality systems, processes, and documentation, ensuring alignment with our QMS, regulatory requirements, and integration objectives.
Lead the mapping, migration, and harmonization of CathWorks quality processes, including document control, training, audits, CAPA, complaints handling, and design control activities, ensuring compliance with FDA, MDR, ISO, and our standards.
Oversee CAPA and complaints management processes, including root cause analysis, corrective and preventive actions, regulatory reporting, and continuous process monitoring.
Provide oversight of software development lifecycle processes, including requirements management, design reviews, validation, testing, and software design controls in regulated environments.
Ensure all quality activities comply with applicable regulatory requirements (FDA, MDR, ISO 13485, 21 CFR Part 11, etc.), including electronic records and signatures, risk management, audit readiness, and support for internal and external audits.
Facilitate communication, training, and stakeholder engagement across CathWorks and Medtronic, identify process gaps, drive continuous improvement initiatives, and monitor integration progress through metrics and regular reporting.

We are looking for a QA/RA Manager to join our team. This is a hands-on, onsite role, based at our offices in New York or Tel Aviv.

Youll be responsible for implementing and executing QA activities throughout the software development lifecycle (SDLC), while supporting the Company compliance in accordance with applicable regulatory standards e.g ISO 13485, ISO 27001, SOC 2, ISO 14971, IEC 62304, HIPAA etc.).

You will work closely with R&D, Product and Operations teams to ensure quality is embedded from design through post-release.

Responsibilities:
Lead and oversee QA/RA activities across the full software development lifecycle (SDLC), including design controls, documentation, verification & validation, traceability, and regulatory compliance (ISO 13485, ISO 14971, IEC 62304, CE/FDA), while supporting release processes and audits.
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Drive continuous improvement of core QMS processes (e.g ECO, CAPA, non-conformances, complaints, document control, management review, suppliers, training, human resources activities etc.), collaborate cross-functionally to enforce quality gates, and provide QA/RA guidance from product concept through post-market activities.

We are looking for a proactive and hands-on Quality Team Leader to lead our quality team and drive continuous improvement across suppliers, production processes, and finished products.

In this role, you'll combine strong people leadership with problem solving, decision making, and cross-functional collaboration. You'll serve as a mentor and role model for your team, while taking ownership of quality performance and identifying opportunities to improve processes and results.



What You'll Do:
Lead and develop a high-performing quality team, driving execution, accountability, collaboration, and continuous improvement across all quality activities.
Manage QMS activities and support compliance with quality standards and procedures.
Lead supplier quality activities, incoming quality control, investigations, and corrective actions.
Support production through real-time problem solving and effective decision making.
Monitor quality KPIs, analyze trends, and communicate insights to management.
Lead audit readiness activities and participate in internal and external audits.
Support onboarding of new materials, suppliers, and NPI initiatives.
Identify opportunities for improvement and proactively drive solutions from idea to implementation.
Lead CAPA, RCCA, and complex root cause investigations.
Manage product and material release activities (MRB / Product Release).
Lead risk management activities (FMEA) and support regulatory compliance.
Manage customer quality issues, complaints, and field performance trends.
Lead cross-functional and global quality projects with R&D, Operations, and Suppliers.