MMÀ propos de Magdalena
Global Quality and Compliance Leader with 20+ years of experience spanning industry, government agencies, and research institutions. Currently working as an independent Quality and Compliance Advisor, supporting organizations in Quality Management Systems (QMS) setup, management systems integration, business transformation initiatives, compliance readiness and auditing. Certified Lead Auditor for ISO 13485, ISO 9001, ISO 14001, and ISO 50001, offering deep expertise in integrated management systems and regulatory compliance.
Proven track record in defining QMS and EEHS strategies, leading Integrated Management System (IMS) transformations, and developing compliance programs aligned with international and local standards (e.g., ISO 9001, ISO 13485, ISO 14001, ISO 50001, 21 CFR 820). Recognized expert in chemical analytics, specializing in analytical measurement quality: Certified Reference Materials, analytical method validation, statistical data analysis, uncertainty budgets, and ISO 17025 compliance.
Experienced in collaborating with global regulatory bodies and international agencies (AOAC, EC, ILSI, FDA), and renowned for exceptional networking and communication skills.
Successfully established the Technical Regulations and Standards (TRS) Compliance Program across GE Steam Power, a supplier audit program at Jabil - Medical Devices, and transformative governance for integrated management systems across 350+ entities at Schneider Electric, ensuring compliance with ISO 9001, ISO 14001, ISO 45001, and ISO 50001.
Adept at leveraging technical expertise and interpersonal skills to drive engagement, motivate teams, and enhance cross-functional collaboration for operational excellence.
Fields of expertise:
- Quality Management Systems: ISO 9001, ISO 13485, ISO 17025, ISO 19443
- Integrated Management Systems: ISO 9001, ISO 14001, ISO 45001, ISO 50001
- Quality Management Systems transformation
- Quality Culture enhancement
- Internal and Supplier Audits
Anglais
Bilingue ou natif
Polonais
Bilingue ou natif
Français
Notions
Accepte de travailler sur site
Zurich (jusqu’à 50 km)
Expériences
- FreelancingQuality and Compliance AdvisorCONSEIL & AUDITfévrier 2025 - Aujourd'hui (1 an et 4 mois)Zürich, SwitzerlandSpecialized consulting and auditing services designed to assist organizations in achieving and sustaining compliance with Quality Management System (QMS) standards (e.g., ISO 9001, ISO 13485) and applicable regulatory requirements. Services are tailored to manufacturers, suppliers, and stakeholders across regulated industries such as medical devices, healthcare, and energy. Beyond compliance, the practice provides strategic advisory in quality system transformation and enterprise-level business transformation, enabling organizations to optimize QMS architecture, integrate risk-based thinking, and align quality and operational excellence initiatives with broader business objectives.
- Schneider ElectricGlobal VP QMSENERGIEnovembre 2022 - février 2025 (2 ans et 3 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 ManagerSECTEUR MÉDICALmars 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.
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Formations
- ISO 13485 lead auditor ISO 9001 Lead Auditor Six sigma black beltISO 13485 lead auditor ISO 9001 Lead Auditor Six sigma black belt
- Doctor of Chemical Sciences (PhD)Gdansk University of Technology2005Doctor of Chemical Sciences (PhD)