Boris Lux

Quality Assurance/Manufacturing Engineering Consultant

Consultant for: CAPA/NC Management

Lead function for Risk Management group related to all products during complete product life cycle. Implementation and maintenance of sufficient risk management methods and procedures. Cooperation with concerned departments to develop the risk management documentation.

CAPA remediation consultant

Quality Assurance during Development - Product development and approval: Covered stents (Fluency Plus, Flair), Balloon Expandable stents (Chromaxx), CE Certification FDA-Approval (510k, PMA) - Risk-Management (FMEA, Matrix analysis, FTA); statistically assured and Risk-Management justified bench test planning (flow chart) and evaluation; Root Cause Analysis during development and manufacturing processes, MAUDE Database Analysis

Quality Management in the biolitec group - Process design and implementation: Process description, knowledge management by using Knowledge Maps - Quality Assurance: world wide manufacturing of diode lasers, clinical probes and optical fibers

Management of improvement process Quality Management-System implementation World wide modification of medical devices