Technical Manager and Process Specialist

Scrap reductions of more than 30% achieved in multiple production environments (MedTech, Automotive) through structured FMEA analyses, CAPA processes, and data-driven process control.

Analytical methods and pragmatic implementation applied as FMEA Moderation and DGQ/EOQ Lead Auditing expertise, establishing sustainable risk assessment, training teams in FMEA logic, and ensuring measurable process stability.

Strategic leadership and operational execution applied in restructuring quality departments, stabilizing processes, and managing successful transitions during handovers to successors.

More than 17 years of auditing experience according to ISO 9001, 13485, 14001, and 45001 enabling rapid stabilization of management systems and secure guidance through external certifications.

Full responsibility for Quality Management, Quality Assurance, and Laboratory Operations

Conducted FMEA-based analysis and reorganization of quality processes to identify systemic weaknesses

Introduced structured CAPA management (8D, SCAR, Root Cause Matrix) for sustainable defect elimination

Significantly reduced scrap and complaint rates (>30%) through process monitoring and staff training

Built and led a cross-functional root-cause analysis team (Production, Engineering, R&D)

Implemented digital deviation and change-management tools integrated with audit and KPI systems

Conducted internal audits and prepared external certifications (ISO 13485, MDSAP)

Provided coaching and knowledge transfer to ensure a stable transition to the successor

Restructured the technical department

Established a Continuous Improvement Process (CIP) to reduce technical downtime causes

Implemented OEE monitoring and failure data analysis to identify key loss drivers

Conducted FMEA workshops with maintenance and production to prevent failures proactively

Optimized maintenance and logistics workflows, reduced technical failures by mor than 20%

Integrated Lean methods into daily management routines and shopfloor meetings

Coached the technical director during the transition phase

Setup & Integration of SCC-FAZ / ISO 9001

Developed and implemented an HSE management system

Prepared for ISO 9001 certification including process design and approval

Defined process interfaces and documentation logic following ISO structure

Established an FMEA-based risk management process for operational activities

Trained management in internal auditing and root cause methodology, resulting in a structured, audit-ready management system as a foundation for certification

Further developed the Energy Management System (ISO 50001) and integrated it into the existing IMS

Defined new process interfaces and risk assessments in line with ISO 9001

Optimized audit cycles and KPI management for energy and quality

Trained management to incorporate new legal requirements, resulting in the full integration of energy management into the IMS structure – zero audit deviations

Introduced Value Stream Mapping and SMED to reduce setup times and minimize internal errors

Defined new performance metrics (FPY, Scrap Rate, MTBF, CAPA cycle time) for targeted process control

Built a Standard Work System and visual management to stabilize processes

Coached team and department leaders on root cause analysis and FMEA thinking

Revised audit and supplier management for preventive defect avoidance

Simplified documentation, checklists, and material inspection requirements (reduced administrative workload by >40%)

Consolidated eight management systems into one integrated system (ISO 9001, 13485, 14001, 45001, 50001)

Harmonized processes and interfaces, defined clear audit structures

Introduced a Europe-wide FMEA framework for standardized risk analysis

Developed a Continuous Improvement Program focusing on OEE improvement and process stability

Created a KPI dashboard (audit findings, FMEA status, CAPA tracking)