Director of Quality Assurance

FIZE Medical is a fast-growing medical device start-up with ground-breaking technology for monitoring critically ill patients, based in Modiin.

About the Job:

Director of Quality Assurance will lead the QA team to ensure strict compliance with regulatory and quality standards for medical devices. This role involves close collaboration with cross-functional teams to support product development and expansion, while ensuring adherence to global regulatory requirements.

Key Responsibilities:

Quality System Leadership

Lead and manage the QA team to ensure ongoing compliance with QMS standards such as ISO 13485, EU MDR, GxP, FDA regulations, and MDSAP.

Oversee internal audits, non-conformance management, CAPA processes, and customer complaints, driving timely and effective resolution of issues.

Audit and Compliance Management

Lead the preparation and management of external audits and implement corrective actions related to MDSAP, MDR, ISO, FDA, and other relevant regulatory bodies.

Serve as the Person Responsible for Regulatory Compliance (PRRC), ensuring compliance with post-market surveillance, reporting obligations, and conformity assessments.

Product Development Support

Quality Improvement

Training and Mentorship

 Experience:

• Master’s degree or equivalent in a relevant field, with 8+ years of experience in quality assurance/control, including leadership roles within the medical device or diagnostics industry.
• In-depth knowledge of MDSAP, MDR, ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations.

Please send your CV to [email protected]