Quality Engineer - Medical Devices

About the role

Medtronic's CathWorks, a digital health business, is looking for a Quality Engineer based in Kfar Saba. The role supports day-to-day quality activities and helps harmonize quality and regulatory processes across the organization, focusing on design controls, CAPA, complaint handling, software development lifecycle activities and regulatory compliance in a regulated medical device environment.

Key responsibilities

• Assist in implementing design control processes, including requirements management, design reviews, verification and validation, and traceability.
• Support mapping, migration and harmonization of quality system processes such as document control, training and audits, and support internal and external audits.
• Integrate and standardize CAPA and complaints handling, ensuring effective root cause analysis and corrective and preventive actions.
• Support software development lifecycle processes, including requirements management, design reviews, validation and testing.
• Ensure processes meet regulatory requirements (FDA, MDR, ISO 13485, 21 CFR Part 11, etc.), including electronic records and signatures, risk analysis and audit readiness.
• Maintain quality documentation, train stakeholders on new or revised processes, identify process gaps and support continuous improvement.

Required profile

• Bachelor's degree in Engineering, Life Sciences or a related field.
• 3+ years of experience in medical device quality engineering, including QMS, design controls, CAPA, complaints management and software validation.
• Working knowledge of FDA, MDR, ISO 13485 and 21 CFR Part 11 requirements.
• Experience with software development lifecycle processes in regulated environments is an advantage.
• Strong analytical, communication and teamwork skills, able to work in cross-functional teams.

Required skills

• QMS, design controls, CAPA, complaints management and software validation.
• Knowledge of FDA, MDR, ISO 13485 and 21 CFR Part 11.
• Experience with QMS integration or harmonization projects and electronic QMS platforms is an advantage.

What we offer

• A competitive salary and a flexible benefits package.
• Eligibility for the Medtronic Incentive Plan (MIP).