Experience

• > 5 years top management of a company with more than 100 employees
• > 20 years management responsibility in different positions
• > 25 years quality management responsibility medical devices (ISO, GMP)
• > 10 years production skills
• > 5 years development and construction experience
• 5 years in a human resources manager position
• More than 200 internal and external audits as lead auditor (ISO 13485 and FDA)

Since 2006 senior consultant for medical device industry (implants, active devices, etc.)   

Projects

• Develop QM-Systems according EN9001 and 13485, 21CFR820 (FDA), MDD and MDR
• Successful certification and recertification with more than 20 companies
• Establish and implement validation concepts in various MedTech-companies
• FDA readiness, compliance and guidance through FDA investigations
• Establish and maintain technical documentations for CE-mark
• Internal and supplier auditing according ISO 9001, 13485 and FDA requirements
• Establishing custom made implant procedure; from X-ray/CT to implant
• Lead in more than 10 FDA inspections
• Coaching more than 15 start-up companies in quality management and product certification
• Giving public lectures about various topics of the medical device industry
• Technical due diligence analysis in aerger and acqusition situations for both sides

Skills

• Medical Devices (orthopedic, spine and ophthalmic implants and instruments, active devices with and without software, therapeutic devices, dental systems)
• Materials (metals and polymers)
• Manufacturing and cleaning procedures
• Quality management and validation of equipment, production and inspection processes
• Cleanliness validation and biocompatibility testing
• Quality system, process and supplier auditing
• FDA Investigation: pre and post audit activities as CAPA plans and communication to FDA
• Spontaneous projects to achieve and/or maintain compliance
• Lead and coach change management processes
• Human resources management and Swiss labour law