Selena Gowland
OGT
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WORK HISTORY
@OGT
EDUCATION
SAQ Qualicon
Certification as Risk Manager L-RM-14-1, Risk Management and Corporate Governance
SGS Academy
Internal Auditor, ISO 13485:2016 Medical Devices
Eurofins BioPharma Product Testing Italy
Biological Evaluation of Medical Devices, including Chemical Characterization
TÜV SÜD Academy Munich
Clinical Evaluations of Medical Devices
Kantonale Diplommittelschule Freiburg
Mittelschuldiplom, Sprachen: Deutsch, Französisch, Englisch, Wissenschaften: Mathematik, Physik, Chemie, Biologie, etc.
Project Management Institute
Certified Associate in Project Management (CAPM), Project Management
SAQ - Swiss Association for Quality
IREB® Certified Professional for Requirements Engineering, Requirements engineering
TÜV SÜD Academy Munich
EC60601-1 Med electrical equipment Pt 1 General requirements basic safety essential performance
BSI Training Academy
CE Marking Medical Devices with Software
TÜV SÜD Academy Munich
Post-Market-Surveillance (PMS) und Post-Market-Clinical-Follow-up (PMCF) of Medical Devices
Swiss Association for Quality SAQ, Berne Switzerland
IREB® Certified Professional for Requirements Engineering
TÜV SÜD Academy Munich
Design Control in Medical Device Development 21 CFR 820 and ISO 13485
SKILLS
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