• Dipl.  Ing. (FH) Computer Science
  • Dipl.  Business Engineer NDS HF
  • Certified Expert Quality Management Medical Devices International


Martin R. Goetschi




Self-employed Specialist for

  • Medical Devices
  • Quality Management
  • Business Process Management
  • Project Management

and Project Manager


  • 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)