Quality Manager for mechatronic components (Sensor Cables, Airbag / safety components) developed and manufactured for global automotive customers. With following key responsibilities:- Management of quality-related matters with multiple international customers, suppliers and internal production sites (following AIAG processes and core tools such like APQP, FMEA, PPAP)- Drive implementation of continuous and sustainable improvements (such as optimized processes and process descriptions)- Support as SME during internal- and surveillance audits (ISO 9001, IATF 16949)- Coordination of customer complaint management (8D report, Root Cause analysis, SAP reporting)

Function as Expatriate at the Gerresheimer site in the United States to locally support the realization of the overall company growing goalsMy engineering efforts contributed to• an expansion project that doubled the existing output of a market-leading autoinjector• the successful implementation of a new generation DPI with subsequent FDA approval• strengthen existing customer relationships which resulted in the win of a high-scaled (>100 million parts p.a.) industrialization projectKey responsibilities included• Drive Process Validation and Risk Management of Medical Device manufacturing processes (autoinjector, DPI, combination product)• Lead contact for customer communication regarding improvement projects, change management, non-conformities, risk assessment and validation strategy• (Integrated) planning and reporting of strategic Quality milestones• SME for internal and external audits (ISO 9001:2015, ISO 13485:2016, FDA 21 CFR 820)

Function as Quality Engineer for international R&D and industrialization projects within a regulated Medical Device environmentMy engineering efforts contributed to• 3 Six Sigma projects that resulted in significant cycle time reductions (savings of 8% - 15%) while maintaining the same quality level• >5 process improvements, in each case leading to effective reduction of reject rates to the strategic goal of <1%• establish solid and sustainable relationships with 2 major Pharma customers, which resulted in follow-up expansion projects with a total volume of >20 million €Key responsibilities included• Coordinate risk-based Process Validation and Implementation of Medical Device manufacturing processes (infusion sets, inhalers)• Initiate and drive successful process improvement projects using Lean Six Sigma Techniques (Kaizen, Poka-Yoke, KT method, DMAIC)• Defining, measuring and reporting of Quality KPIs (OEE, CNQ, CAPA, reject rate)• Lead SME for customer communication regarding Quality operations (Validation, Risk Management/FMEA, Change Management, Improvement Projects incl. Effectiveness Checks)

Assist various engineering departments (Automation Engineering, Process Development, Quality Engineering) with Medical Device - R&D Projects Bachelor Thesis: "Designfokussierte Realisierung eines Mikroadapters für die ophthalmologische Anwendung"Degree(s): Mechatronics Technician (Apprenticeship) and B.Eng. - Mechatronics (Study)