Quality Management Consultant

• Responsible for QM and QA departments with 22 employees
• Managed personnel and budget planning
• Built and further developed the entire quality organization
• Redesigned the complaint management system for efficiency and sustainability
• Streamlined and advanced company processes
• Planned and monitored projects for quality improvement
• Defined and optimized relevant process and departmental KPIs

Successes:

• Implemented quality planning in advance for new development projects
• Completely restructured the CAQ system
• Established a supplier management system and introduced new contracts
• Implemented new testing equipment to boost efficiency
• Introduced AQL and shifted inspections to suppliers
• Systemically secured medical device production

• Implemented a standardized approach to product development and approval
• Moderated workshops for process optimization
• Supported several optimization projects
• Performed GAP analysis and updated product files in accordance with current regulations

Successes:

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

• Restructured the quality management system according to DIN ISO 9001
• Unified three national subsidiaries under one certificate
• Conducted external and internal audits
• Designed a continuous improvement process
• Provided training and coaching for quality staff

Successes:

• Achieved multiple successful certifications by SQS
• Completed site harmonization
• Introduced and documented CIP, and implemented several pilot projects successfully
• Conducted Q-methods training and coached application

• Formed and led a taskforce for sustainable resolution of acute quality issues in the automotive sector
• 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
• Developed necessary knowledge among leaders and staff through coaching and training
• Revised the entire inspection concept for intermediate and final inspections

Successes:

• Assembled a taskforce from quality assurance, operational excellence, and production
• Introduced common methods such as Ishikawa, 5-Why, Value Stream Mapping, SPC, etc.
• Established operator self-inspection in production areas
• Eliminated additional externally performed 100% inspections
• Successfully resolved all customer escalation scenarios

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

Successes:

• Achieved multiple successful certifications by DEKRA
• Developed a successful concept for MDSAP implementation
• Increased average supplier rating by 10%
• Secured three successful medical device approvals (Class I and IIa)

• Documented existing company processes and conducted GAP analysis against DIN ISO 9001 requirements
• Optimized processes and created an English-language QM system
• Planned the production layout for series manufacturing of the first product line

Successes:

• Introduced and certified a QM system according to DIN EN ISO 9001
• Built a series production environment for cobots

• Worked in electrical engineering and photovoltaics

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

• Worked in medical technology, diagnostic instruments