Experience

• > 15 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 / EN 9100 and ISO 13485, 21CFR820 (FDA) and MDD / MDR
• 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