Quality Engineer (Medical Devices)

Location: Kefar Sava, Central, Israel

Company

hirify.global is a healthcare technology company developing medical devices, including the CathWorks FFRangio® System, which uses AI and computational science to assess coronary physiology from routine angiograms.

What you will do

• Support design control processes, including requirements management, design reviews, verification, validation, and traceability.
• Help map, migrate, and harmonize quality system processes such as document control, training, and audits.
• Participate in CAPA and complaint-handling activities, including root cause analysis and corrective and preventive actions.
• Support software development lifecycle processes, including requirements, design reviews, validation, and testing.
• Maintain quality documentation, train stakeholders, identify process gaps, and support continuous improvement.
• Help ensure quality processes remain compliant and audit-ready.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3+ years of experience in medical device quality engineering.
• Experience with QMS, design controls, CAPA, complaints management, and software validation.
• Working knowledge of FDA regulations, MDR, ISO 13485, and 21 CFR Part 11.
• Strong analytical, communication, and teamwork skills for cross-functional collaboration.

Nice to have

• Experience with software development lifecycle processes in regulated environments.
• Experience with QMS integration or harmonization projects and electronic QMS platforms.

Culture & Benefits

• Full-time employment with hirify.global.
• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Employee resources designed to support different career and life stages.