About Magdalena
English
Native or bilingual
Polish
Fluent
French
Basic
German
Basic
Experience
- Schneider ElectricGlobal VP QMSNovember 2022 - Today (3 years and 7 months)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 ManagerMarch 2021 - October 2022 (1 year and 7 months)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 - February 2021 (1 year and 10 months)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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Education
- 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
Skill set
Categories
- Other