Quality Assurance Expert in Medical Device Industry

Quality Management Systems
Expertise in ISO 13485, FDA 21 CFR Part 820, ISO 9001, and EU MDR requirements for medical device quality management systems

Supplier Quality Management
Implementation and monitoring of supplier quality management processes, conducting supplier evaluations and qualifications

Qualification and Validation
Creation and coordination of qualification and validation plans (IQ, OQ, PQ) for products, processes, systems and cleanrooms

CAPA Management
Experience with root cause analysis and corrective actions implementation, including creation of 8D reports

Auditing
Certified internal auditor for ISO 13485, ISO 9001, and EU MDR with experience conducting internal and supplier audits

Technical Documentation
Creation and management of quality management documents ensuring compliance with applicable standards and regulations

Software Proficiency
Experience with Microsoft Dynamics AX, SAP, MS Office, Excel, and PowerPoint for quality management documentation