Strategic Quality Leadership – Proven experience in leading and optimizing QMS for medical devices, ensuring compliance and continuous improvement
Regulatory & Risk Management Expert – In-depth knowledge of risk-based approaches, CAPA, auditing, and regulatory frameworks for global market access
Process Optimization & Digitalization – Strong focus on data-driven decision-making, ERP implementation, and digital transformation in quality processes
Hands-on Project & Supplier Management – Extensive experience in supplier qualification, cross-functional project leadership, and stakeholder collaboration
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Overview
- Availability
- 01.09.2025; 5 days/week; on-site & remote
- Qualification
- M.Sc. Quality Engineering, Expert Quality Management Medical Devices (TÜV Rheinland), Information Security Officer (TÜV Süd)
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Medical Devices, ISO 9001, ISO 13485, ISO 27001, Auditor, CAPA, VCS, Project Management, Supplier Management & Qualification, Statistic, Document Control, Professional SCRUM Master
Key-Facts
Extract from Previous Activities
MedTech Company, Germany
Quality Consultant
Advised on ISO 9001 & AZAV compliance for internal QMS
Led process digitalization & optimization projects
Conducted training & coaching for quality teams
Provided project management support for operational excellence
MedTech Company, Germany
Quality Assurance Engineer
Developed inspection & sampling plans to enhance product quality
Led the selection & implementation of a new ERP system
Programmed and optimized optical & tactile measuring systems
Established statistical methods for quality monitoring and reporting
MedTech Company, Germany
Supplier Management & Compliance Audits
Conducted supplier qualification & supplier audits for ISO compliance
Managed CAPA processes & risk assessments
Improved documentation & regulatory compliance (ISO 13485, ISO 9001)
Led internal process validation projects to meet industry standards