Reinhard Goswin

Qualitätsmanagement Technische Dokumentation und Regulatory Affairs in der Medizintechnik

risk management, usability, clinical evaluation, gamma sterilization validation, packaging validation, cleaning validation, re-processing validation

Head of QM/RA Department (15 empl.) DIN EN ISO 13485:2016, MPG, MDD 21 CFR Part 820 (USA), JPAL & MHLW Ordinance # 169 (Japan) and CMDR (Canada). MDSAP Audits, Working on MDR preparation. WW Supplier Audits (EU, Far East), Tech Doc (150 TF), different notified bodies Regulatory Affairs (Europe, USA, Canada, Japan, Korea, China etc.) Training and education of employees Processing of complaints, and CAPA Document Control (20000 docs) Safety officer (§ 30 MPG)

Team Lead for 4 employees Representing the Quality Manager Internal and supplier audits in German and English, Quality management system, Corrective and preventive actions (CAPA) Monitoring of suppliers, Document Control (app. 8000 technical and non-technical documents)

Quality planning, supplier Audits, moderating FMEA and monitoring actions, establish process capabilities (Cp, Cpk), MSA.

Implementing and Maintaining a Multi-Site Quality Management at 14 locations in Germany and Austria, a Document Management System and Quality Circles Conducting Internal and supplier audits Project Manager for the development of cellular base stations

Development of the certification body, Responsibility for 4 lead auditors, More than 100 audits at windows, doors and accessories manufacturers in Germany, Austria, Italy and Switzerland as lead auditor, Hold QM courses, Several publications Software Development

Building physics, Development of finite element software (PASCAL, C++), Project Manager R&D projects, Hold seminars on building physics Conducting tests Quality Manager of the Institute (since 1992) Establishing a quality assurance system and accreditation according to EN 45001