Senior Manufacturing Quality Engineer (Medical Devices)

TL;DR

Senior Manufacturing Quality Engineer (Medical Devices): Ensuring products are manufactured in compliance with quality standards and regulatory requirements for Class III medical devices with an accent on QMS maintenance, CAPA processes, and audit support. Focus on leading investigations, root cause analysis, implementing corrective actions, and driving continuous improvement initiatives.

Location: Onsite Yoqneam Illit, North, Israel

Company

Global leader in healthcare technology developing medical devices to alleviate pain, restore health, and extend life.

What you will do

• Maintain and improve the Quality Management System compliant with ISO 13485, EU MDR, and FDA QSR.
• Support manufacturing, validation, MRB, and CAPA activities on the production floor.
• Oversee nonconformances, deviations, complaints, risk management, change controls, and training.
• Participate in internal and regulatory audits, including preparation and follow-up.
• Collaborate with R&D, Regulatory Affairs, Operations, and Supply Quality teams.
• Lead investigations of nonconformances and deviations with root cause analysis and corrective actions.

Requirements

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related field
• 7+ years of QA production experience in medical devices
• In-depth knowledge of FDA 21 CFR Part 820, ISO 13485/14971, and EU MDR
• Strong analytical and problem-solving skills
• Strong communication skills in English, written and verbal
• Hands-on experience with ECOs, nonconformance management, CAPA, and root cause analysis tools

Nice to have

• Knowledge of Lean, Six Sigma, or continuous improvement methodologies

Culture & Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through hirify.global Incentive Plan (MIP).
• Commitment to employee contributions with wide range of resources and compensation plans.
• Global team focused on innovation, diversity, and solving health challenges.