לוח משרות דרושים הייטק אבטחת איכות QA בנהריה

We are a growing medical device company operating in global markets, committed to the highest standards of quality, innovation, and regulatory compliance.
We are seeking an experienced and highly motivated QA & RA Director to lead our Quality Assurance and Regulatory Affairs activities and ensure full compliance with international standards.

Key Responsibilities:
- Act as the Management Representative for the Quality Management System (QMS) 
- Lead the implementation, maintenance, and continuous improvement of the QMS in accordance with ISO 13485, FDA, and MDR requirements 
- Ensure full compliance with international regulatory standards, including EU MDR, FDA, and CE marking requirements 
- Oversee quality processes, including internal and external audits, cleanroom monitoring in accordance with ISO 14644, and process control 
- Manage customer complaints and post-market feedback (PMF), including CAPA processes 
- Handle non-conformities and drive continuous improvement initiatives across the organization 
- Maintain and update quality procedures and work instructions 
- Lead regulatory activities, including submissions, responses, and ongoing compliance across global markets 
- Manage relationships with Notified Bodies, regulatory authorities, and external consultants 
- Oversee and approve subcontractors and suppliers, including quality system evaluations 
- Conduct training programs to ensure company-wide QMS awareness and compliance 
- Report regularly to senior management on QMS performance and regulatory status 
- Work closely with cross-functional teams, including R&D, Operations, Marketing, and Sales 

Additional Details:
Full-time position, on-site (non-hybrid).