Quality Program Manager

About the role

The Quality Program Manager will lead the integration of CathWorks quality systems into Medtronic’s global quality framework. Based in Kfar Saba, this onsite role ensures alignment of design controls, CAPA, complaints handling, software development lifecycle, and regulatory compliance.

Key responsibilities

• Work with the Integration Lead to plan and align quality systems, documentation, and processes with Medtronic’s QMS and regulatory requirements.
• Lead mapping, migration, and harmonisation of CathWorks quality processes, including document control, training, audits, CAPA, complaints handling and design control activities.
• Oversee CAPA and complaints management, root‑cause analysis, corrective actions, regulatory reporting and continuous monitoring.
• Provide oversight of software development lifecycle processes, including requirements management, design reviews, validation, testing and software design controls.
• Ensure compliance with FDA, MDR, ISO 13485, 21 CFR Part 11 and support internal and external audits.

Required profile

• Bachelor’s degree in Engineering, Life Sciences or related field; Master’s preferred.
• 7+ years of experience in medical device quality management, including QMS integration, design controls, CAPA and software validation.
• Strong knowledge of FDA regulations, MDR, ISO 13485 and 21 CFR Part 11.
• Demonstrated project management and leadership skills with ability to drive cross‑functional initiatives.

Required skills

• CAPA management
• Design control processes
• Software development lifecycle oversight
• Regulatory compliance (FDA, MDR, ISO 13485, 21 CFR Part 11)