Dear,
I would like apply for the job.
I have more then 7 years of experience in the following areas:
Systems (Quality Management System, Medical Device Management System, Risk Management, Management and Preparing TF for CE Mark),
Develop Systems for Quality Management, Monitoring and Trace-ability (Quality Supervision System, Staff Knowledge Management , TF Management, Barcoding and Labeling Management),
Processes (R&D, Software, Design, P&L, Production, Risk Control, Technical Service, Sales, IT, Transfusion Blood Separation and Blood Banks, Incoming Control, Processes Control, Quality Control, Design Verification, UM, Packaging Management Processes, HR Processes, Internal and External Training and Education, Design Verification, Validation Process, Control of Monitoring and Measuring Equipment, Meeting Management, Project Management, Customer Requirements Management, Selection and Evaluation of Suppliers, Management of Nonconforming Products, Change Management, Monitoring System Improving),
Improvements (PDCA, KaiZen Method, FMEA, Pareto Analysis, Ishikawa, CAPA and RCA, 5 Why, SWOT Analysis),
Standards (ISO 9001, ISO 13485, ISO 14971, EN 62366, EN 62304, ISO 19011, EN 60601, ISO 2859-1, MDD, RoHS2 Directive),
Auditing (Internal Audit of QMS, External Audit of QMS, Supplier Audit, Systems Audit, Products Audit, Processes Audit).
I am looking forward to hearing your answer.
Best regards,
Aleksandar Siskovic