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Reinhard Goswin

Selbstständig, Inhaber, Qualitätsmanagement Technische Dokumentation und Regulatory Affairs
Raubling, Germany

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 2019

    Project "Technical Files for bone drills and surgical Instruments"

    aap Implantate AG

    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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