You will be responsible for the CAPA process and ensure that corrective and preventive actions are systematically implemented
Job Summary
You will be responsible for the CAPA process and ensure that corrective and preventive actions are systematically implemented.
You will plan, coordinate, and accompany audits by customers and authorities, with the follow-up and implementation of necessary measures also being your responsibility.
You will create and review quality-relevant documents such as declarations of conformity and certificates and manage our document management system.
Matching Summary
You will be responsible for the CAPA process and ensure that corrective and preventive actions are systematically implemented.
Skills & Requirements
Must-have
DIN EN ISO 9001
DIN EN ISO 13485
IVDR
CAPA process
Change management process
Document management system
Nice-to-have
Communication with authorities
Analytical thinking
Structured working method
High attention to detail
Team player
Key Requirements
Degree in Natural Sciences, Medical Technology, Quality Management or similar
First professional experience in Quality Management
Regulatory knowledge (IVDR, ISO 9001, ISO 13485)
Experience in audit preparation, execution, and follow-up
Knowledge of CAPA processes and Change Management
Proficiency with digital tools and reporting systems (Power BI, SAP Analytics)