Assist with the hosting and management of client audits.
Support Continuous Improvement program and conduct internal meetings to support management of issues
Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities
Excellent leadership, analytical, organizational and communication skills
Analyze any observations identified and work with applicable departments to generate effective corrective and preventive action responses
Develop auditing plans and compile reports for assigned audits