Compliance Specialist

Main Duties:

• Coordinating and tracking of CAPA system
• Performing root cause analysis related to CAPA
• Creating monthly analysis of CAPA status
• Conducting internal and suppliers' audits
• Follow up internal audits NCS tracker
• Creating monthly analysis of internal audits status and NCS
• Coordinating, performing and tracking suppliers’ audits
• Creating monthly analysis of suppliers’ audits status
• Updating and maintenance of quality procedures
• Support external audits
• Assisting with different quality projects

Requirements:

• Bachelor’s degree in a relevant field such as Life Sciences or Engineering.
• 2-3 years of experience in compliance, regulatory affairs, or quality assurance within the medical device industry.
• In-depth knowledge of ISO 13485, FDA regulations, and other relevant standards and regulations.
• Familiarity with Good Manufacturing Practices (GMP).
• Lead auditor certification – an advantage.
• Demonstrated skills in failure investigation and root cause analysis.
• Strong documentation skills.
• Fluent English - writing, reading, and speaking.
• Strong understanding of quality management systems.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• High attention to detail and organizational skills.