Experience

• Over 7 years' experience in medical device industry in varioous job roles
• Over 10 years' experience in quality management in various positions and industries
• Over 3 years' managerial experience in variuous job roles
• Responcible for quality management and regulatory compliance of medical devices for over 4 yeras (ISO, FDA)
• Over 4 years' experience as a quality engineer working with medical devices and in the automotive, aviation, space and defence industry
• Over 5 years' experience in production
• Lead auditor for internal and external audits (ISO 13485, FDA and AIAG 16949)

Projects

• Development and maintenance of QM-systems according ISO 9001 / 13485, MDD/MDR,  21CFR820 (FDA), part 11 (FDA)
• Successful certification and recertification with various companies
• Establish and implement validation concepts in MedTech and automotive companies
• Audit and inspection readiness, compliance and guidance through NB Audits and FDA investigations
• Internal and supplier auditing according ISO 9001, ISO 13485, FDA, and AIAG 16949 requirements
• Implementation and maintenance of CAQ Systems incl. software validation
• Computer system validation according part11 (FDA)
• Implementation of Best Practices in CAPA, deviation management, audit and Inspection

Skills

• Quality management practices
• Validation of equipment, production, inspection processes
• Computer software validation according GAMP 5
• Pre and post audit activities in conjunction with notifed body audits and FDA inspections
• Expert in manufacturing process
• Quality system, process and supplier auditing
• Intercultural communication