תיאור המשרה
Description
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.
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