Katarzyna Gumowska
Quality Manager at Ada Health- Claim this Profile
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Bio
Credentials
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Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Training Course
BSIApr, 2023- Sep, 2024 -
Digital Architect: eConsent
Medable, IncJun, 2021- Sep, 2024 -
Risk Management (ISO 14971:2019, MDR / IVDR)
NSF InternationalDec, 2020- Sep, 2024 -
Internal Auditor ISO 13485:2016 Medical devices quality management systems
BSIOct, 2020- Sep, 2024 -
QMS ISO 9001:2015 Lead Auditor Course
DNVApr, 2018- Sep, 2024 -
PRINCE2 Foundation Certificate in Project Management
AXELOS Global Best PracticeJul, 2017- Sep, 2024 -
Internal Auditor of IMS ISO 9001:2015, ISO14001:2015, OHSAS 18001:2017
iQuelleJun, 2017- Sep, 2024 -
Good Clinical Practice
The National Institute on Drug Abuse (NIDA)Aug, 2020- Sep, 2024
Experience
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Ada Health
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Germany
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Hospitals and Health Care
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200 - 300 Employee
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Quality Manager
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Feb 2022 - Present
- Implementing and maintaining quality management system in line with ISO 13485:2016 and MDR for Notified Body (TÜV SÜD) certification audit - Developing and implementing company's QMS in branches (US, UK, Canada, Singapore) - Supporting Regulatory Affairs in placing product on the markets (EU, US, UK, Canada, Singapore, Switzerland, Brazil and others) - Ensuring QA for products' life-cycle and change management activities (software design, development and validation and CSV in line with IEC 62304:2006) - Driving quality events processes (CAPA, NC, customers' and users' feedback, InfoSec and privacy related incidents, audit findings) - Managing internal and external audits plan and its execution - Qualifying new suppliers (including vendors' audits) - Establishing and revising the current quality processes (including writing SOPs, WIs) - Ensuring QA in projects - Providing training sessions to relevant parties About Ada Health: SaMD: clinically driven AI, symptoms checker, telemedicine Some customers: Pfizer, Bayer, Novartis, NHS, Ontario Health Show less
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Medable, Inc
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United States
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Software Development
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300 - 400 Employee
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Auditor
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Sep 2021 - Feb 2022
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Quality Assurance Specialist
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Jun 2020 - Sep 2021
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Beerenberg
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Norway
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Oil and Gas
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500 - 600 Employee
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Group Quality Assurance and ISO Coordinator
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Aug 2015 - May 2020
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Arteria Association
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France
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Civic and Social Organizations
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Administrative and Financial Coordinator and PR Manager
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Oct 2010 - Apr 2016
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PR Manager
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Sep 2014 - Oct 2015
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Assistant of International Department / Festival Office
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Sep 2010 - Sep 2015
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PR Manager
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Mar 2014 - Jun 2015
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PR Manager
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Mar 2012 - Oct 2012
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Book Editor, Project Manager
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Dec 2010 - Jul 2011
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Project Manager “European Night of Museums”
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Mar 2010 - May 2010
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Office Manager, Education Department Assistant, Curator Assistant
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Aug 2009 - Sep 2009
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Office Manager
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Apr 2005 - Sep 2009
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Education
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2021 - 2021
UCLA Extension
course -
2006 - 2011
University of Gdansk
Master of Arts
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