• Dipl. Ing. (FH) in Informatics & Dipl. Business Engineer NDS HF (state diplomas recognized by Switzerland)
• Expert Quality Management Medical Devices International
  (TÜV Rheinland personnel certification no. 3094498 acc. to examination regulation ID 27230)
  

• freelance specialist for Quality Management (QM) and compliant QM processes in the medical device industry
  (ISO 13485, 21 CFR Part 820, EU-MDR, et al.) since mid-2014
  

• CAPA SME (Subject Matter Expert)

• 4 years' experience as responsible Quality Management Representative in the medical device industry:
  - achievement and preservation of ISO 9001 / ISO 13485 certification considering MDD (93/42/EEC) and GMP compliance to
    gain CE certification for class IIa medical devices
  

• more than 10 years' experience as Coordinator and Project Manager for ERP system and organizational projects

1. Establishment and maintenance of QM systems according to ISO 13485:2016 and 21 CFR 820 (QSR) in the medical device industry

• QM projects with a focus on processes and procedures:
• • Carrying out gap analyses of the QM system regarding compliance with regulatory requirements, such as ISO 13485, QSR or
    EU regulation 2017/745 (EU MDR)
  • Implement regulatory compliant, efficient and effective processes, work instructions and templates individually adapted to company needs:
  • • Customer projects conducted for CAPA, R&D, design transfer and procurement processes
  • Compilation of the technical documentation according to EU MDR Annex II and III for class I, Ir, Is, IIa and IIb products

2. CAPA SME (Subject Matter Expert)

• Hands on CAPA support, especially for extensive and complex CAPA
• CAPA remediation considering regulatory requirements
• CAPA process efficiency enhancement
• CAPA training for all experience levels

3. Customer complaint handling using 8D report

4. Project management and coordination for projects

• Focus on QM, organization and ERP projects

5. Holistic project management system

• Establish and implement

6. Business Process Management

• Process map creation (business, management and support processes)
• BPM 2.0 (Social Business Process Management)

7. Organizational development

• Troubleshooter
• Excellent analytical skills
• Analyze – Structure – Synthesize
• Entrepreneurial thinking and targeted action
• Strong social competences
• Strong team player and strong capability to work independently
• Quick wit, communicative, intuitive, visual thinking, proactive and imaginative
• Constant search for new challenging tasks and to take on complex scopes
  

Language (level of experience)

• German (native language, including High German and Swiss German)
• English (fluent)
• French (intermediate)
• Italian (basic)