QA Team Leader - Medical Devices (ISO13485)

Are you a quality-driven professional with leadership experience in medical devices? Do you thrive in a dynamic, fast-paced environment where your impact directly contributes to life-saving innovations? If so, we want you on our team!

Who We Are

Rapid Medical is a fast-growing medical device company dedicated to developing, manufacturing, and delivering groundbreaking devices for endovascular interventions. Our innovations improve patient outcomes worldwide, and we’re looking for talented professionals to join our mission.

About the Role

We are seeking a QA Team Leader to lead and manage our Quality Assurance (QA) team in ensuring that our products and processes meet the highest quality and regulatory standards. This is a hands-on leadership role where you’ll oversee QA operations, guide a dedicated team, and collaborate cross-functionally to drive continuous improvement.

LOCATION: Yokneam, Israel.

What You’ll Do

• Lead QA Operations: Oversee the team’s activities, ensuring compliance with regulatory requirements and internal quality standards.
• Manage Change Controls: Supervise Engineering Change Orders (ECOs) and Document Change Orders (DCOs) to ensure proper risk assessment and implementation.
• Own NCR & CAPA Processes: Drive Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA) to resolution.
• Support Production Quality: Work closely with manufacturing teams to maintain the highest quality in production and cleanroom environments.
• Ensure Compliance & Audit Readiness: Participate in internal and external audits, including FDA inspections and ISO13485, EUMDR, and MDSAP audits.
• Proactively Solve Quality Issues: Address and resolve quality challenges efficiently to keep operations running smoothly.

What We’re Looking For

• Education: B.Sc. in Science or Engineering.
• Experience: 5-7 years in medical device QA (ISO 13485, FDA QSR 820).
• Industry Knowledge: Experience in manufacturing and cleanroom environments.
• Certifications: Internal auditor certification.
• Skills: Strong leadership, attention to detail, self-learning ability, and ability to work under pressure.
• Languages: High-level English (written and spoken).
• Tech Skills: Experience with Priority ERP – an advantage.