Certified Auditor - ISO 13485, ISO 9001, CE mark, TF (MDD 93/42/EEC)
I have more then 7 years of experience. I am a certified auditor for medical device (ISO 13485) and QMS (ISO 9001).
Jobs: Auditing, Risk Management, Quality Management, Regulatory Requirements, Process Control, System Improving, Quality Assurance process of production medical devices and laboratory devices in accordance to ISO 9001, ISO 13485, ISO 14971 and MDD (93/42/EEC).
• Audit of process according the requirements of ISO 9001, ISO 13485, MDD (93/42/EEC),
• Preparation of a Technical Files for Medical Devices (CE marking - Technical file requirements, Review of the Technical Files, Documenting the Technical Files),
• Preparation company for external audit (TÜV SÜD Germany - Certification Body),
• Quality Assurance Processes (Research and Development, Software, Production, Quality Controls),
• Monitoring, measurement, process analysis, improvement of processes,
• Preparing QMS documentation of processes in according with the requirements of ISO 13485, ISO 14971, ISO 9001, ISO 19011, EN 62366, EN 62304, EN 60601,
• Ensuring compliance process with requirements of ISO 9001, ISO 13485, ISO 14971, MDD,
• Modeling and implementation of Quality Supervision Portal (QSP),
• Analysis of defects and failures in the production (RCA and CAPA),
• Preparation of a RoHS2 Technical documentation Process and RoHS2 Technical Files,
• Risk Analysis - Failure Modes and Effects Analysis for Medical Devices,
• Education of employees for quality according to the requirements of ISO 9001 and ISO 13485,
• Supplier Audit according to the requirements of ISO 9001,
• Methods (KaiZen Method, Kanban, 5S, Pareto Analysis, Ishikawa, 5 Why),
I have experience in the following areas:
Systems (Quality Management System, Medical Device Management System, Risk Management, Management and Preparing TF for CE Mark),
Standards (ISO 9001, ISO 13485, FDA 21 CFR 820, ISO 14971, EN 62366, EN 62304, ISO 19011, EN 60601-1, EN 60601-1-2, MDD 93/42/EEC, RoHS2 Directive),
Auditing (Internal Audit of QMS, External Audit of QMS, Supplier Audit, Systems Audit, Products Audit, Processes Audit).
Develop Systems for Quality Management, Monitoring and Trace-ability (Quality Supervision System), TF Management, Barcoding and Labeling Management),
Improvements (PDCA, KaiZen Method, FMEA, Pareto Analysis, Ishikawa, CAPA and RCA, 5 Why, SWOT Analysis).
My approach is PDCA.