Israel, Caesarea - Operation Quality Manager

Job Description:

We are currently searching for an experienced and highly analytical Quality Manager to join our Quality Assurance department to support the QMS & Operational activities.
As the Quality Manager, you will uphold the safety regulations of our company and supervise the product flow process to guarantee that all our products & Process meet quality and Regulatory compliance expectations.
To excel in this role, applicants should demonstrate great attention to details with excellent technical and interpersonal abilities

Duties and responsibilities:

Manufacturing Quality Monitoring

• Act as a Quality approval for manufacturing process & layout changes
• Monitor all process to meet Regulatory guidelines (FDA, EU and other applicable regulations)
• Monitoring online production quality results, allocate risks and implement solutions
• NC & MRB Management
• Lead internal and external quality system audits
• Inspect and monitor US site Quality process.
• Supplier Quality monitoring including Suppliers audits, Incoming Goods & SCARS.
• Monitor Calibration of test equipment

Design Quality Support:

• Ensure FDA, EU and other regulatory requirements are meet in Design Control process.
• Participates in the Design Reviews, design transfers and in all other aspects of the Design Control process.
• Monitoring product development activities and documentation, especially Design Review meetings, Risk Analysis meetings.

Requirements

• Quality Manager 3+ Years of relevant experience in Medical Device industries.
• Previous experience of Global regulatory requirements such as: FDA (QSR) and EU MDD/MDR, ISO requirements
• CQE (Certified Quality Engineer) qualification – Preferred,
• Strong written/verbal communication skills in Hebrew & English
• Well organized, Highly motivated and independent
• Team player and collaborator.

Please send resume and cover letter to [email protected]