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Quality Assurance Manager
PresencialTiempo completoManufacturing Quality ManagementMedical Devices
Manage the quality system for a clinical-stage implantable medical device in a multidisciplinary development environment. This full-time, office-based role is located in Petah Tikva and reports to the Head of Quality Assurance.
Responsabilidades
- Help implement and maintain the quality system in a multidisciplinary R&D environment.
- Maintain the Design History File and ensure design records are complete, controlled, and traceable.
- Manage product configuration, Device Master Records, Engineering Change Orders, and manufacturing documentation.
- Control procedures, specifications, forms, and other documents.
- Manage quality records, including retention, traceability, and accessibility.
- Maintain the Approved Supplier List and supplier quality documentation.
- Maintain equipment logs and calibration and maintenance records.
- Work with R&D, regulatory, manufacturing, and suppliers to integrate quality requirements into development.
Requisitos
- BSc or equivalent in engineering, life sciences, biomedical sciences, quality, or another relevant technical or scientific field.
- At least 2 years of experience in quality assurance, engineering, operations, or a related role in a regulated medical device environment.
- Experience with design controls, DHF, DMR, ECOs or configuration management, and document control.
- Familiarity with medical device quality management systems and applicable quality processes.
- Strong organization, attention to detail, ownership, and ability to work across multidisciplinary teams.