Gaby Lemberger
QA Manager at xxxxx | Augsburg, Bavaria, Germany
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Gaby Lemberger is a highly experienced QA Manager specializing in medical technology, with a comprehensive expertise in quality assurance, process validation, and regulatory compliance. Currently, she plays a pivotal role at xxxxx, where she leads the integration and implementation of the Medical Device Single Audit Program (MDSAP), ensuring seamless adherence to international standards such as ISO 13485 and risk management protocols. As a Lead Auditor and responsible for MDSAP build-up, Gaby conducts internal auditor training, fostering a culture of continuous improvement and compliance within the organization. Her proficiency in CAPA (Corrective and Preventive Actions), non-conformance management, and process improvement initiatives significantly enhances product quality and operational efficiency.
In her role, Gaby oversees the qualification and validation of production processes and equipment, manages supplier relationships, and ensures the integrity of technical documentation and approval processes. She is also responsible for KPI monitoring, which provides critical insights into quality metrics and process performance, enabling data-driven decision-making. Her expertise extends to integrating electronic document management systems like ELO, streamlining documentation workflows, and supporting regulatory audits.
Gaby’s project management skills are evident in her leadership of cross-functional teams, from production to customer support, ensuring timely project execution and accurate offer calculations. Her deep understanding of risk assessment, process validation, and quality management systems positions her as a key driver of quality excellence at xxxxx. Her strategic approach to quality assurance, combined with her technical acumen in mechatronics and risk management, ensures the organization maintains compliance, enhances product safety, and achieves operational excellence in a highly regulated industry.
QA Manager at xxxxx in May 2018 to Present
Qualitätsingenieur at XXXXX in April 2009 to April 2018
Qualifizierungs- und Validierungsbeauftragte at Medizinprodukteunternehmen in January 2002 to January 2009
Technischer Projektmanager at Sondermaschinenbau in January 1996 to January 2002
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IVM Engineering, June 1994
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Fehleranalyse
Anweisung
Interne Kommunikation
Analytische Kompetenz
Überprüfung
ISO
Qualitätsförderung
Internationale Normen
DIN
Kunden-Support
Koordination
Lieferantenbewertung
Fehler-Ursachen-Analyse
Schulung
Prozessentwicklung
ISO 9001
Technisches Training
Klärung
Überwachung
Riskiobewertung
Problemlösung
Lieferantenqualität
Liebe zum Detail
Lieferantenaudits
Technisches Schreiben
Lieferanten-Qualitätsmanagement
Mechatronik
Deutsch
Lieferantenmanagement
Risikomanagement
Redigieren
Failure Mode and Effects Analysis (FMEA)
Lieferantemanagement
KPI
KPI-Reporte
Kontinuierliche Verbesserung
Audits
Maschinenbau
Qualitätsmanagementsystem
Fertigung
CAPA
Integration
Dokumentation
Validation
Personalschulungen
Qualitätsaudit
Reinigungsvalidierung
Projektleitung
Prozessvalidierung
Quality Assurance; Quality Audits; Quality Control; Quality Reviews
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Discover more about xxxxxWhat is Gaby Lemberger email address?
Email Gaby Lemberger at [email protected]. This email is the most updated Gaby Lemberger's email found in 2026.
How to contact Gaby Lemberger?
To contact Gaby Lemberger send an email to [email protected]. (updated on March 24, 2025)
What company does Gaby Lemberger work for?
Gaby Lemberger works for xxxxx
What is Gaby Lemberger's role at xxxxx?
Gaby Lemberger is QA Manager
What is Gaby Lemberger's Phone Number?
Gaby Lemberger's phone (**) *** *** 390
What industry does Gaby Lemberger work in?
Gaby Lemberger works in the Medical Devices industry.
Gaby Lemberger Email Addresses
Gaby Lemberger Phone Numbers
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