m.buegelnoSpam@axxos.noSpamch

• SAQ-qualified quality expert medical device field
• Qualified environmental systems manager- ISO 14001
• Chemical lab technician, subject area analytics
• IRCA certified lead auditor ISO 13485:2016

Senior Consultant at Axxos AG since 2015

Experience

• >10 years in medical device industry
• Head of quality management in medical engineering, metal and cosmetics industry
• Establishment and management of a testing lab for polymer technology
• Optimisation of equipment, processes and methods

Projects

• Installing, running and optimising of quality management systems ISO 9001 + ISO 13485
• Key position in developing medical devices of classes I, IIa + IIb
• Experience in medical device field, especially in dental (composites) and orthopedics (spine & trauma)
• Process optimization in polymer-, coating- and cleaning techniques in polymer and metal industry
• Implementation and evaluation of CAQ systems
• Implementation of CAQ software (Babteq)
• CAPA management
• Planning and executing of trainings in hygiene and concepts

Skills

• Medical device field
• Polymer technology (thermoplasts, impact extrusion)
• Damage and failure analysis polymer parts
• Metal industry (processing of aluminium, impact extrusion)
• Planning and optimising manufacturing and cleaning processes
• Audit according to ISO 9001, ISO 13485, ISO 14001
• Clean room monitoring