Daniel Helbling

d.helblingnoSpam@axxos.noSpamch

    • MSc in Sport and Moving Science
    • CAS Paralegal
    • Several trainings in quality management, project management
      and complaint handling
    • IRCA certified lead auditor ISO 13485:2016

      Senior Consultant at Axxos GmbH since 2018

        Experience

        • > 10 years in quality management of medical device industry
        • > 8 years at a market authorization holder of medical devices in the area of complaint management and vigilance
        • 3 years as quality representative at a contract manufacturer for pharmaceutical, medical device and in-vitro-diagnostic companies
        • > 7 years management responsibility in different positions within quality (max. 26 employees)
        • 2 years part of management team of a company with more than 100 employees

        Projects

        • Successful design and implementation of quality processes using different quality management softwares (TrackWise, Pilgrim, SAP QIM)
        • Establish, maintain and optimize QM-systems according to ISO 9001 and ISO 13485, RL 93/42 EWG (MDD), 21CFR820 (FDA)
        • Complaint management, reporting to and communication with competent authorities
        • International, multi-site optimization projects for the complaint handling, CAPA, change process
        • FDA readiness, preparation for and translation at FDA inspections (front- and backroom)
        • Internal and supplier audits according to ISO 9001, ISO 13485 and 21CFR820 (FDA requirements)

        Skills

        • Medical devices (orthopedic and traumatological implants and instruments, therapeutic devices)
        • Combination products (inhalers, autoinjectors)
        • In-vitro-diagnostic products (cuvettes, vials, consumables)
        • Materials (metals and polymers)
        • Complaint handling / root cause analysis / communication with competent authorities
        • Quality management processes e.g. change control, document control, nonconformity, CAPA, management review
        • System (QMS), process and supplier audits
        • FDA inspection support

        My personal scrabble