Quality Engineer

About the role

Medtronic’s CathWorks division is seeking a Quality Engineer to support day‑to‑day quality activities and harmonise quality and regulatory processes across the organisation. Based in Kfar Saba, you will work on design controls, CAPA, complaint handling, software development lifecycle and regulatory compliance for medical devices.

Key responsibilities

• Assist in aligning and implementing design control processes, including requirements management, design reviews, verification/validation and traceability.
• Support mapping, migration and harmonisation of quality system processes such as document control, training, audits and related activities.
• Participate in integration and standardisation of CAPA and complaints handling, ensuring effective root‑cause analysis and corrective actions.
• Support software development lifecycle activities, including requirements management, design reviews, validation and testing.
• Ensure all processes meet regulatory requirements (FDA, MDR, ISO 13485, 21 CFR Part 11) and maintain audit readiness.

Required profile

• Bachelor’s degree in Engineering, Life Sciences or related field.
• 3+ years experience in medical device quality engineering covering 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.

Required skills

• Design control processes
• CAPA and complaints handling
• Software development lifecycle in regulated environments
• Regulatory standards: FDA, MDR, ISO 13485, 21 CFR Part 11
• Electronic QMS platforms (advantage)

What we offer

• Competitive salary and flexible benefits package
• Short‑term incentive through the Medtronic Incentive Plan (MIP)
• Opportunities for professional growth in a global healthcare leader