Quality Management Consultant

• Responsible for QM and QA departments with 22 employees
• Conducted personnel and budget planning
• Built and further developed the entire Q organization
• Redesigned the complaint management for efficiency and sustainability
• Improved and streamlined company processes
• Planned and monitored projects for quality improvement
• Defined and optimized suitable process and departmental metrics

Successes:

• Introduced quality planning for new development projects
• Completely restructured the CAQ system
• Established supplier management, introduced new contracts
• Implemented new testing equipment to increase efficiency
• Introduced AQL and shifted inspections to suppliers
• Systemic safeguarding of medical device production

• Implemented a standardized approach to product development and approval
• Facilitated workshops for process optimization
• Supported multiple optimization projects
• Conducted GAP analysis and updated product files according to current regulations

Successes:

• Established a project management process including APQP application
• Optimized incoming goods inspection by introducing AQL and adjusting supplier management
• Converted inventory and line supply to a Kanban system
• Introduced the pull principle and reduced inventory levels
• Digitalized production lines by providing ERP, CAQ, and manufacturing control software
• Built a regulatory affairs department to ensure approvals
• Provided compliant product files

• Restructured the quality management system according to DIN ISO 9001
• Merged three national subsidiaries under one certificate
• Supported external audits and conducted internal audits
• Designed a continuous improvement process
• Trained and coached employees in quality management

Successes:

• Multiple successful certifications by SQS
• Completed site harmonization
• Introduced and documented a CIP and successfully ran several pilot projects
• Conducted training on quality methods and coached on application

• Built and led a task force to sustainably solve acute quality issues in the automotive industry
• Implemented quality standards for efficient error detection, problem solving, and complaint handling
• Prepared and supported regular customer audits (VDA 6.3)
• Adapted existing processes and integrated new standards
• Built necessary knowledge among leaders and staff through coaching and training
• Revised the entire testing concept for intermediate and final inspections

Successes:

• Task force composed of quality assurance, operational excellence, and production
• Introduced methods like Ishikawa, 5-Why, value stream mapping, SPC, etc.
• Established operator self-inspection in production
• Eliminated additional external 100% inspections
• Successfully closed all customer escalation scenarios

• Optimized the QMS according to DIN ISO 13485 and DIN ISO 9001
• Prepared for certification under MDSAP
• Optimized complaint and CAPA management
• Supported global product approvals
• Built a supplier management system

Successes:

• Multiple successful certifications by DEKRA
• Developed a successful concept for implementing MDSAP measures
• Increased average supplier rating by 10%
• Completed three successful medical device approvals (Class I and IIa)

• Documented existing company processes and conducted GAP analysis according to DIN ISO 9001 requirements
• Optimized processes and developed an English QMS
• Planned production layout for series manufacturing of the first product line

Successes:

• Implemented and certified a QMS under DIN EN ISO 9001
• Built a series production environment for cobots

• Worked in electrical engineering and photovoltaics

• Worked for commercial vehicles, trailers, and semi-trailers

• Worked in medical technology, diagnostic instruments