Operational Quality Assurance Manager.

Position Overview:

A Quality Assurance Manager is responsible for ensuring that the daily operations of manufacturing and production processes meet the required quality standards.

It involves monitoring and improving the quality of products and processes within the organization. overseeing and enhancing the quality assurance processes within the manufacturing and production operations.

The QA Manager will lead the quality control team and oversee the quality issues raised as part of the operations and production. This role ensures compliance with regulatory standards, improves quality processes, and supports product manufacturing activities to maintain high-quality standards.

requirements:

Minimum of 5-7 years of experience in quality assurance/quality control within the medical device/pharma industry.

Experience with QMS implementation and maintenance, including ISO 13485 and FDA QSR requirements.

Proven track record in managing regulatory inspections and audits.

Strong knowledge of medical device regulations and standards (FDA, ISO 13485).

Proficiency in quality management software and tools.

Fluent in English.

Experience with Lean Six Sigma methodologies.

Experience in the cardiovascular field or implants – advantage

Certified Quality Auditor credential - advantage.

Reporting to the company’s QA & RA Director

Location: Tel Aviv (Not hybrid)!