Job description
As a Quality Management System (QMS) Manager at Bactiguard, you will be responsible for leading QMS compliance, audits, Corrective and Preventive Actions (CAPA), and regulatory readiness to ensure the quality of medical devices and drive continuous improvement.
Responsibility
- Lead and oversee QMS compliance in accordance with ISO 13485 standards
- Conduct internal and external audits to ensure quality standards are met
- Develop and implement CAPA strategies to address quality issues
- Ensure regulatory compliance and readiness for inspections
- Drive continuous improvement initiatives to enhance product quality
Qualification
- Bachelor's degree in Engineering or related field
- Proven experience in quality management in the medical device industry
- Strong knowledge of ISO 13485 and regulatory requirements
- Excellent communication and leadership skills
- Attention to detail and analytical mindset