
Reinhard Goswin
Skills
Timeline
Professional experience for Reinhard Goswin
- Current 5 years and 11 months, since Apr 2019
Inhaber
Qualitätsmanagement Technische Dokumentation und Regulatory Affairs
Qualitätsmanagement Technische Dokumentation und Regulatory Affairs in der Medizintechnik
- 5 months, Apr 2019 - Aug 2019aap Implantate AG
Project "Technical Files for bone drills and surgical Instruments"
risk management, usability, clinical evaluation, gamma sterilization validation, packaging validation, cleaning validation, re-processing validation
- 2 years and 3 months, Jan 2017 - Mar 2019
Quality and Regulatory Affairs Manager
Medi-Globe Technologies GmbH
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)
- 2015 - 2016
Quality & Regulatory Affairs Manager
Medi-Globe Corporation
- 2008 - 2014
Quality & Regulatory Affairs Manager
Medi-Globe GmbH
- 2003 - 2007
Quality Compliance Manager and Auditor
Bausch & Lomb Technolas, Munich
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)
- 2002 - 2003
Quality Planner and Auditor
WET Automotive, Odelzhausen (former Ruf Electronics, Ruf Automotive)
Quality planning, supplier Audits, moderating FMEA and monitoring actions, establish process capabilities (Cp, Cpk), MSA.
- 1999 - 2002
Quality Manager, Management Representative
Hörmann GmbH, Kirchseeon (Communication networks / Warning Systems)
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
- 1994 - 1999
Deputy Head of the Certification Body, Lead Auditor
Institut für Fenstertechnik, Zertifizierungsstelle, Rosenheim
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
- 1989 - 1994
Construction Physicist, Quality Manager
Institut für Fenstertechnik e.V., Rosenheim
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
Educational background for Reinhard Goswin
- 1982 - 1989
Physik (Diplom)
University of Heidelberg, Hamburg and Würzburg
Languages
German
First language
English
Fluent
French
Basic
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