Krzysztof Kucharski

Validation, ECR/ECO , PPV, VAVE

Transfer and commissioning project of CNC Heller machines for the production of mechanical modules of automatic transmission gears of VW and Audi for the BorgWarner customer carried out in AE Group DE.
Maintaining Machines for High Pressure Deburring by Silberhorn and tunnel pressure washers Semmelroth.

Reporting to VP Quality Director and Plant Manager
Making decisions in complex business situations
Coordination of cooperation between the production, logistics, customer service and quality departments
Inspiring and mentoring task and project teams
Quality budget management
Qualitative management of the production processes of advanced medical hearing diagnostic devices
Cooperation with R&D on solving problems of electronic medical devices in the field of production and complaints from external customers and distributors
Management and supervision of medical audits, internal QMS, deviation approval processes
Quality KPI management for In-House Quality and indicators of individual product brands
Making decisions about the approval of products on the basis of technical and quality analyzes
Cooperation with sourcing in the development of suppliers of components for the production of medical devices.
Making decisions on full and conditional approvals and release for use of materials
Motivating and maintaining the team at a high level of effectiveness using the latest techniques.

Reporting to EMEA Quality Director and Plant Manager
Responsible and accountable for right quality of products and processes
Carry out In-Process Control Audits, Daily Gemba Walk
Maintain Customer Complaints and Customer Services on local and EMEA level

Drive Customer Complaints Review Process with Production, Logistic, Planning, Product Managers,
Customer Service, Sales and Carriers
Master of 8D Advanced methodology
Cooperate with EMEA Supplier Development Team in terms of supplier claims, disputes and development
Maintain Inbound, Production, Kitting, Outbound and Quality Block Stock in terms of Quality of processess efficiency,
Cost of Poor Quality

Preparing Quality Control Plans for key processes, machines
Preparing Material Inspection Plans of itemes delivered by external suppliers
Process Scrap Reduction Management, Dedicated Manfufacturing Scrap Reduction Projects
Manufacturing Record Books for Key Customers and Inspections
Manage and Coordinates process o Deviation Requests,
Drive process of FAAR (First Artical Approval Report) on local and EMEA level,
Lead Quality Complaince Documentation like CoC (Certificates of Conformance), TR (Test Reports),
COO (Country of Origin) and similar

Process FMEA for production and functional areas
Quality Supervising of introduction of new products and their variants
Cooperate with Products Management and R&D, Create and maintain CTQ Flowdown for key parts
Close cooperation with Customer Service on Customer Experience
Managing Quality Measurement and Reliability Lab.
Leading implementation of DQIP (DIGITAL QUALITY INSPECTION PLANS) project.
Conduct Gage R&R for weight balance operations
Manage Calibration process.
Manage 25 people of QA Controllers, QA Engineers and Senior QA Engineer
Coordinate QMS, ISO 9001:2015 Recertification Project
Creating EMEA Competence Center for Carbon Foot Print (CFP); Environment Product Declaration (EPD) ;
Life Cycle Assesment (LCA), ISO 14067:2018, ISO 14064:2018

Customers and 3-rd Parties audits ( in example: BV, SGS, Intertek)
Creating and equiping Quality Lab. (dimensional measurements, reliability and
destructive tests for heat shrink tubes).

Fulfillment Centre Change Management processes and projects at operations area and support functions.
Improvement and Lesson Learn Projects leadership
Lean Logistic Projects
Building Maintenance projects leadership
KPI dashboard supervising
Safety Housekeeping audits
5S management, Kaizen
Bus transportation coordination, Utilization Management
Canteen management
Voice of Associates Board coordination
FC Capex CARs and Opex Budget management
Cooperation with regional Universities.

Maintain and develop Lean Culture for DGS Campus.
Conduct Kaizen Events including Value Stream Mapping Sessions and Problem Solving Process Workouts according to Danaher. Creating and running Strategy for BTE Lean Manufacturing.
Achieve Productivity targets and continuously work with budget.
Yearly working on vision to meet Road Map Steps of World Lean Class Manufacturing.
Drive cross functional Strategic Projects (acc. to Prince2) for secure short and long term production growth in terms of safety, space, infrastructure, assembly and supporting processes, material flow, cost and quality of product and assembling activities.
Optimize production of hearing instruments through internal projects including manufacturing set up, standards (5S and 5S PLUS), line balancing (Value Stream Mapping, TPM, SMED, MTM-1, MTM-UAS) and both jobs and material flow , (Kanban Systems) in order to increase productivity of BTE production (Behind The Ear Instruments).
Implement White-Custom Model Production for new products and variants according to QRM principles
(Quick Response Manufacturing according to Prof. Rajan Suri)

Strong participation in New Products Introduction Processes for variants and brand new products in terms of assembly structure, material flows, CFMs, PFMEA, CTQ Flowdown, layouts, technology, optimization and ramp up phase after transfer.
Design assembly layouts according to Long-U-Shape No Name for White items and Short-U-Shape Named for customized ones.
Very close co-work with High Volume Engineering upon automation of bottleneck processes (replacing manual high time consuming processes by semi-automated ones)
Managing Standard Times of FG items (phantoms, no name and named items)
Create Work In Progress Material Capacity Visual Management
Design and implement Jobs Kanban System for the No Names Production.

Drive N.A.T.I. (New Assembly Technology Introduction) for improving assembling lines by searching, selecting and verifying right mounting technics solutions and technology suitable for reducing throughput time, increase line’s capacity and make them scalable as well as secure quality robustness of products.
Cooperation with Danish R&D on New Product Introduction since first lab. series up to final one, designing CFMs for the final lab.
Managing and developing Kaizen process to excellence.
Invent and Run BTE Lean Academy (graduating system, internal trainings, workshops for both white and blue collars)
Six Sigma projects coordinator.

Quality of products and service as well as assembly and supporting processes.
QMS.
Budget of quality control, preventive and service costs.
Maintain PFMEA analysis for critical processes and new introducing parts or operation.
Manage Quality Control Plans for technology and assembly processes.
Drive suppliers improvement and development projects.
Lead parts, materials and resources cost reduction projects through cooperation with R&D dept.
(Italy, Sweden, Germany)
Manage measurement laboratory and parts validation
Lead Increase Warehouse Capacity Project
Supervising product’s homologation process, internal and VDE
Meet quality KPI’s at targets (NRFT, Scrap, ARI, Service Call Rate)
Maintain Quality Management System (ISO standards 9001, 14000).

Quality of products and assembly processes
Managing Cost of Poor Quality
Leading process of Customer Claims and Disputes Handling
Quality Management System, ISO 9001
Drive Cost saving, Defects Reduction and Six Sigma projects
Maintain CTQ and CTP Flowdowns of processes and critical parts
Design and validate machine for quick testing low current breakers
Perform Gage R&R analysis of critical processes
Products audit by UL.

Quality of products and assembly processes
Quality Management System
Realization transfers of electro acoustical components for hearing aid instruments
Customer complaint handling process
Manage FMEA , SPC processes
Leading suppliers improvement program
Cooperate with Dutch R&D on validation of backplate charging machine for electret microphones.
Design machine for matching magnets for receivers mounted in hearing instruments

Servicing small domestic machine, cost control
Maintain introduction on market small vibration-dotting machine Couth

Design and Installing electrical system for anchor winches at naval rescue ship
Make Integration system of Rudders stream and anchor winches