Über Magdalena
Global Quality and Compliance leader with 20+ years of experience across industry, government agencies, and research institutions. Proven expertise in defining Quality Management System (QMS) strategies, leading Integrated Management System (IMS) transformations, and developing audit programs aligned with international and local regulations and standards. Lead auditor for ISO 9001 and ISO 13485. Skilled in leveraging technical expertise and interpersonal abilities to drive engagement, motivate teams, and enhance cross-functional collaboration for operational excellence.
Englisch
Muttersprachlich oder zweisprachig
Polnisch
Verhandlungssicher
Französisch
Grundkenntnisse
Deutsch
Grundkenntnisse
Vor Ort möglich
Zurich (bis zu 50 km)
Projekt- und Berufserfahrung
- Schneider ElectricGlobal VP QMSNovember 2022 - Heute (3 Jahre und 7 Monate)Zürich, Switzerland• Orchestrated IMS governance for 350+ entities, driving management systems transformation.• Ensured compliance with ISO 9001, ISO 14001, ISO 45001, and ISO 50001 standards, collaborating with Notified Bodies to secure ISO certifications.• Oversaw a network of 2000 auditors maintaining quality standards across 50 countries.• Enhanced organizational capability by deploying advanced auditors training programs.
- JABIL HEALTHCARESenior Regulatory Compliance ManagerMärz 2021 - Oktober 2022 (1 Jahr und 7 Monate)Balstal, SO, Switzerland• Led ISO 13485 compliance efforts across 9 EU sites, focusing on Medical Devices standards.• Supervised internal, supplier, and external audit programs.• Championed the development, implementation, and oversight of Continuous Inspection Readiness Programs, ensuring seamless compliance with regulatory standards.
- Johnson & Johnson/ Jabil HealthcareRegulatory Compliance ManagerApril 2019 - Februar 2021 (1 Jahr und 10 Monate)Solothurn, Switzerland• 6 months under Johnson & Johnson.• MD Orthopedics branch transferred to Jabil in October 2019.• Enhanced compliance with ISO 13485, EU MDR, FDA 21 CFR 820, and MDSAP regulations for robust quality management standards.
Empfehlungen
Sei die erste Person, die Magdalena empfiehlt
Teile Deine Erfahrung aus der Zusammenarbeit mit diesem Freelancer.
Diese Freelancer passen auch zu Ihren Kriterien
Agatha Frydrych
Backend Java Software Engineer
4.7
(3)
2
Baptiste Duhen
Fullstack developer
4.6
(4)
5
Amed Hamou
Senior Lead Developer
4
(2)
7
Audrey Champion
Web developer
4.3
(3)
4
Ausbildung und Abschlüsse
- Doctor of Chemical Sciences (PhD)Gdansk University of Technology2005Doctor of Chemical Sciences (PhD)
- Master of Science in BiotechnologyGdansk University of Technology2001Master of Science, Engineer (M.Sc. Eng.)
Zertifizierungen
- Lead Auditor ISO 9001IRCA | International Register of Certificated Auditors2015
- Lead Auditor ISO 13485The Knowledge Academy2019
Fähigkeiten
Kategorien
- Sonstige