Quality Program Manager (Medtech)

TL;DR

Quality Program Manager (Medtech): Integrating CathWorks quality systems and processes into hirify.global's global quality framework with an accent on design controls, CAPA, and regulatory compliance. Focus on harmonizing QMS, overseeing software development lifecycle in regulated environments, and ensuring FDA/MDR alignment.

Location: Onsite in Kfar Saba, Herzliya, or Tel Aviv, Israel

Company

A global leader in healthcare technology focused on alleviating pain, restoring health, and extending life through innovative medical technologies.

What you will do

• Lead the integration of quality systems, processes, and documentation into hirify.global’s global QMS.
• Harmonize quality processes including document control, audits, CAPA, and complaints handling.
• Oversee the software development lifecycle (SDLC), including requirements management and validation in regulated environments.
• Ensure compliance with FDA, MDR, ISO 13485, and 21 CFR Part 11 standards.
• Manage stakeholder engagement and identify process gaps to drive continuous improvement.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 7+ years of experience in medical device quality management (QMS integration, CAPA, software validation).
• Strong knowledge of FDA regulations, MDR ISO 13485, and 21 CFR Part 11.
• Proven project management and leadership skills.
• Must be based in Israel (Onsite).

Nice to have

• Master’s degree.
• Experience with large-scale QMS harmonization projects.
• Familiarity with electronic QMS platforms and Software Design Controls.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan (MIP).
• Opportunity to work for a global leader in healthcare technology.
• Purpose-driven career focused on improving patient lives.