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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 Manager 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).