Steinen, Baden-Württemberg, Germany
Integration, harmonization and further development of METTLER TOLEDO Swiss market organization´s processes. Enhancement and improvement of QM system to further strengthen partnership with leading Swiss pharma&biotech key customers.
• Member of the unit Executive Board; • Manage QMS acc. to ISO 9001 and ISO/IEC 17025, MT internal standards & QM EU handbook to assure: Product- & Process compliance, Complaint handling, Audit management, Continuous Improvement, HSE • Manage Test Equipment (Weights & other References ) for overall 90 Service field-service technicians): Organize qualification (re-calibration), certificates & records, deviation & OOS handling • Pipette Calibration lab: Assure techn. compliance to ISO/IEC 17025:2018, ISO 8655:2022, customer requirements, and customer SOPs, SOP review, approval and implementation of cGxP requirements • Trusted Advisor Customer to support customers in all technical and compliance related questions • CAPA management & follow-ups • Develop & enhance local quality management system and further integrate into/within European MO system • Review & approve customer requests, QAA/QSV, contracts and agreements in collaboration with Legal Contract Champion (LCC) and global stakeholders (legal counsil, MT internal stakeholders, customers) • Leading improvement campaigns and projects (LEAN, CIP, 5S, CX NPS) on unit level • Plan & conduct process (customer) audits/assessments and GEMBA walks in lab area as well as unit internal Audits in CH/EU, and within MT network (EU cross audits) as lead Auditor • Reporting & review of quality KPIs within MO and EU Region Central organization • Site Responsible for Service site North Basel (~30 people): budget, site development, local services) • Compliance and Cyber Security unit delegate • Assorted projects: (1) Lead AI project to support region EU QMS, (2) Lead local implementation of Global Pipette Service Solution (GPSS) E2E calibration tool, (3) Support implementation of CRM/depot calibration process, (4) Project lead for Customer Portal - Calibration ordering process (techn. and commercial compliance), (5) Support CX qualtrix NPS unit introduction, (6) New service introduction for calibration services.
Head Quality Management, Mettler-Toledo Logistik GmbH, European Logistics Hub – EU-HUB, Naenikon, Switzerland • Member of the Executive Board; • Unit responsible for: Quality management, Product- & Process compliance, Complaint handling • Develop and enhance local quality team in Switzerland as well at 3rd Party Logistics (3PL) partner in the Netherlands (NL) • Enhance processes and Standards (business continuity management, risk management, continuous improvement) • Responsible for execution of internal/external improvement campaigns and projects (e.g. LEAN back-office, CIP) at 3PL (DOJO, 5S, LEAN) • Prepare and conduct internal/external trainings in CH and NL • Plan and conduct process audits/assessments and GEMBA walks at 3PL/NL as well as unit internal Audits in CH • Complaint handling: Support root cause analysis in collaboration with Strategic Business Units (SBUs), Production Organizations (POs) in Asia, Europe, USA and the 3PL in NL • Support and enhance MT quality processes: Global SAP QN E2E-Process, material handling, reporting concept • Reporting and review of quality KPIs within MT global Supply Chain Organization EU-HUB and on global HUB Level
• Quality Manager: Quality & Environmental Management according to ISO 9001/14001, Supplier Quality Management, Return-/Claim Management, Test & Production Quality (Overall 6 HCs): Budget, team development • Supplier qualification and management, conduct supplier process au-dits according to VDA6.3 (ISO/TS 16949) in Eastern Europe, China • Project manager for quality-/operations related projects, improvement projects, with focus on: Yield stabilization, root cause analysis, technical changes, returns processes • Implement corrective and preventive actions – CAPAs and supplier follow-ups • Quality assurance for new product developments and/or changes: Quality Gates, p-D-FMEAs, approvals • Manage transfer projects: Product- and process transfers, quality planning, monitor ramp-up / start of production, on-site trainings, support customer audits • Plan and conduct product-/process qualifications according to VDA2, PSW, PPAP, MSAs, Gage R&Rs • Reporting of quality KPIs
• Monitor yield in high precision temperature-, flow- and moisture sen-sor production lines • Implement and enhance statistical process control (SPC) • Plan and conduct process and measurement system capability stud-ies (MSAs, Gage R&Rs) • Plan and conduct design of experiments (DoE) • Identify critical processes and process steps • Implement new technologies and processes in serial production • Conduct feasibility studies (requirement analysis, supplier selection, communication, support make or buy decision)
• Work in a multidisciplinary life-science project to develop a highly in-tegrated Sphincter prosthesis system (active medical implant) • Develop MEMS microfluidic structures and systems • MEMS cleanroom fabrication • FEM-/CFD-Simulation and analytical calculations • Research and develop innovative substrate bond technologies • Technical Consultant for a 3rd party funded project (∼1.5 Mio.€ investment volume), design and develop MEMS structures and process technologies