À propos de 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.
Anglais
Bilingue ou natif
Polonais
Capacité professionnelle complète
Français
Notions
Allemand
Notions
Accepte de travailler sur site
Zurich (jusqu’à 50 km)
Expériences
- Schneider ElectricGlobal VP QMSnovembre 2022 - Aujourd'hui (3 ans et 7 mois)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 Managermars 2021 - octobre 2022 (1 an et 7 mois)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 Manageravril 2019 - février 2021 (1 an et 10 mois)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.
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Formations
- 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.)
Certifications
- Lead Auditor ISO 9001IRCA | International Register of Certificated Auditors2015
- Lead Auditor ISO 13485The Knowledge Academy2019
Compétences
Catégories
- Autre