13.04.2026 aktualisiert
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Qualitätsingenieur | Qualitätsmanager | Auditor
München, Deutschland
Nur Remote
B. Eng. Industrial EngineeringÜber mich
Ich unterstütze Organisationen im Aufbau und in der Pflege von QM‑Systemen. Mein Fokus liegt auf der Weiterentwicklung von QMS‑Prozessen, Risikomanagement nach ISO 14971, Usability, Validierungen und Biokomp, Auditbegleitung, MDR‑ und QMSR‑Anforderungen sowie klarer technischer Dokumentation.
Skills
21 CfrAuditmanagementBiokompatibilitätCertified Professional Medical AuditorChange ManagementComplianceIEC 60601Iec 62304Iso 13485ISO 14971ISO13485Operational Risk ManagementQualitätsmanagementVerifizierung und ValidierungTechnische Dokumentation
Quality Management Systems
ISO 13485, ISO 14971, IEC 62304, IEC 60601, ISO 10993 standards implementation and compliance management
Supplier Management
Supplier audit management, selection processes, assessment, qualification, ranking and non-conformance handling
Process Control and Validation
Production process control, process validation and technical documentation management
Medical Device Sterilization
Sterilization processes for medical devices according to regulatory standards
MDR Compliance
Medical Device Regulation compliance and implementation
Project Management
Project coordination and management methodologies
Corrective and Preventive Actions
Enforcement of corrective and preventive actions, Stoppage of non-conformities to assure safeness and effectiveness of the products
Complaint Handling
Handling of customer complaints including informing competent authorities and notified body
Sprachen
DeutschMutterspracheEnglischverhandlungssicherSpanischGrundkenntnisse
Projekthistorie
Contributing to the design transfer process to and from suppliers, ensuring compliance with internal and external requirements, handling supplier audit management, supporting the supplier selection process, establishing and maintaining systems for supplier assessment, qualification, and ranking, handling supplier non-conformances, implementing and maintaining processes for supplier management and continuous development.
Coordination of risk management activities, supporting design transfer activities, enforcement of corrective and preventive actions, stoppage of non-conformities to assure safeness and effectiveness of the products, handling of customer complaints, preparing and updating of technical documentations, supporting on/offsite audits, coordinating biocompatibility evaluations.
Execution of change management procedures to improve production processes, enforcement of corrective and preventive actions, stoppage of non-conformities to assure safeness and effectiveness of the products, handling of customer complaints including informing competent authorities and notified body, qualification, coordination, control and management of suppliers, implementing of QM-Processes such as qualification and validation of equipment, representation of Quality Management in product development activities.