לוח משרות דרושים בוגרי מדעי החיים בכפר סבא, לחיפוש זה נמצאו 4 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.

As a Quality Engineer based in Kfar Saba, you will play a key role in supporting day-to-day quality activities while helping harmonize quality and regulatory processes across the organization. This position focuses on design controls, CAPA, complaint handling, software development lifecycle activities, and regulatory compliance within a regulated medical device environment. You will collaborate with cross-functional teams to ensure quality system requirements are effectively implemented, maintained, and continuously improved, supporting the delivery of innovative technologies that advance patient care.

Responsibilities may include the following and other duties may be assigned:
Assist in aligning and implementing design control processes, including requirements management, design reviews, verification/validation, and traceability.
Support the mapping, migration, and harmonization of quality system processes, including document control, training, audits, and related quality activities; support internal and external audits as applicable.
Participate in the integration and standardization of CAPA and complaints handling processes, ensuring effective root cause analysis, corrective and preventive actions.
Support software development lifecycle processes, including requirements management, design reviews, validation, and testing.
Ensure all integrated processes meet applicable regulatory requirements (FDA, MDR, ISO 13485, 21 CFR Part 11, etc.), including electronic records and signatures, risk analysis, and audit readiness.
Assist in updating and maintaining quality documentation, provide training to stakeholders on new or revised processes, identify process gaps, and support continuous improvement initiatives.