Cirruculum Vitae

On the professional market since 1997

I am eager to contribute my experience and skills to support the success of your organization.


Krzysztof Kucharski

Szczecin, Poland


krzysztof.tadeusz.kucharski@gmail.com

+48 728 866 932


Education

Technical University of Szczecin

Electrical Enginnering Master of Science


Information Technology 

(Postgraduate Studies)


University of Szczecin

Business Management (Postgraduate studies)

SME Areas

Quality Management

Supplier Quality Management

Leangineering

Six Sigma

Project Management

Software Validation

Process Validation

Injection Molded Parts Validation

Injection Moulding Machine and Tool Validation

Risk Assessment

Gamp 5 Second Edition

Regulatory

ISO 9001

ISO 14001

ISO 45001

ISO 27001

ISO 13485

MDSAP

FDA 21 CFR Part 820

FDA 21 CFR Part 11 ERES

Coding

Python

Visual Basic

Turbo Pascal 5.5

 

Design Engineer

Service Manager

Head of QA

Quality Director

Quality Manager

CI & Lean Manager

Operation & Change Manager

Quality Manager

Quality Manager

QA Specialist Global


Core Strengths and Expertise

I am a strategic Quality and Engineering professional with a rare blend of technical depth,

managerial experience, and forward-looking digital competence.

My strength lies in bridging traditional Quality Assurance with modern IT and AI tools, driving operational maturity, and leading diverse teams toward measurable performance excellence across multiple

high-compliance industries.


Quality & Validation Leadership: Deep experience in software, equipment, and process validation across regulated industries (Medical, Automotive, Energy).

Proven track record with quality and suppliers managementinjection moldingtest methodslaser weldingautomated inspection systems (ML), and QMS (ISO 9001, 13485, MDSAP, FDA 21 CFR Part 820 and Part 11 ERES) environments.


Advanced Manufacturing and Lean Management: Expert in LeanSix SigmaKaizenFMEAPRA, PPRA, 8DPPAP, SMED, QRM, CTQ Flowdown and Digital Quality Inspection Plans (DQIP).

Known for driving continuous improvement and operational excellence through structured methodologies.


Project and Change Management:

Demonstrated success in cross-functional and cross-site projects, including machine transfersprocess optimizationautomation, and new product introductions (NPI).

Experienced with Prince2PPAP, and MFU frameworks.


AI and Data-Driven Quality Systems: Currently advancing skills in PythonAzure DevOps,

and AI model selection for Quality Assurance.

Applying machine learning concepts to risk assessment, validation, and process control in industrial and medical contexts.


Leadership Philosophy: A people-oriented leader guided by John C. Maxwell’s “5 Levels of Leadership”, emphasizing mentorship, empowerment, and maturity of organizational culture.

Recognized for fostering high-performing teams and developing individuals through coaching and structured growth programs.


Technical Breadth: Background spanning electrical designindustrial automationsoftware integration, and robotics logistics systems.

Broad experience working closely with R&DEngineeringProductionIT, and Laboratories.


Career Highlights

  • Radiometer Solutions: Global validation specialist leading multiple validation streams (software, molded parts, test methods, machines, and sensors) within a global medical device environment.

  • DGS Diagnostics & Tyco Electronics: Managed full Quality departments in complex medical and energy manufacturing plants. Established KPIs, led audits, improved supplier development, and integrated digital quality systems.

  • Amazon Robotics Fulfillment Center: Led operational change management and Lean improvement projects in an advanced robotics logistics environment.

  • DGS Poland (Oticon): Drove Lean transformation and implemented Quick Response Manufacturing and Value Stream Optimization across large-scale production lines for hearing instruments.

  • Electrolux & GE Power Controls: Delivered product and process quality improvements, supplier development, and cost optimization across multiple international production units.

  • Early Career (Autocomp Electronic & Sztormland): Developed a solid technical foundation in electrical systems integration, marine automation, and industrial equipment design.


  • Employment History

    Radiometer Solutions

    Stargard (West Pomeranian Region)

    2022-02-01 >> Present Day

    Quality Validation Specialist, Global

    Software Validation, Injection Molded Parts Validation, Injection Machines Validation, Test Method Validation, Test Station Validation, Laser Welding Validation, Quality Specification, Engineering Changes, Automatic Optical Inspection of planar electrochemical sensors.

    Brand: Medical Device

    Business Improvement Group Lean Solutions Inc.

    Strzelce Krajeńskie (Lubuskie Region)

    2021-06-01 >> 2022-02-01

    Project Manager  (Borgwarner Resident at AE Group DE)

    Software Validation, Injection Molded Parts Validation, Injection Machines Validation, Test Method Validation, Test Station Validation, Quality Specification, Engineering Changes

    Brand: Automotive


    Aluminum housings for VW and Audi automatic transmissions gears type DL501, DQ250 and DQ381

    Managing transfer, installation and commissioning of Heller CNC machines.

    Maintain Validation Process, PPAP and MFU documentation

    Commissioning of automatic High Pressure Deburring Robotic Washers Machines of Silberhorn and Semmelroth

    DGS Diagnostics

    Szczecin (West Pomeranian Region)

    2020-10-01 >> 2021-06-01

    Quality Manager

    Brand: Medical Devices


    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


    Tyco Electronics Poland

    Szczecin (West Pomeranian Region)

    2019-01-01 >> 2020-10-01

    Quality Manager

    Brand: Energy Connectivity


    Kits and connectors and fitting of Low, Medium and High Voltage, Power Systems, Heat Shrink Tubing, Surge Arresters

    Main Responsibility & Accountability:

    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


    Amazon Robotics Fulfillment Center Poland

    Kołbaskowo (Szczecin, West Pomeranian Region)

    2017-08-01 >> 2019-01-01

    Operations & Change Manager

    Brand: E-commerce Robotics’ Logistic


    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


    DGS Poland (Oticon Poland)

    Mierzyn (Szczecin, West Pomeranian Region)

    2010-09-01 >> 2017-08-01

    Continuous Improvement & Lean Manager

    Brand: Medical Devices


    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.


    Electrolux Poland

    Żarów (Lower Silesia Region)

    2006-10-01 >> 2010-09-01

    Quality Manager

    Brand: Household appliances (Dishwashers Electrolux, AEG)


    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)


    General Electric Power Controls Poland

    Kłodzko (Lower Silesia Region)

    2005-08-01 >> 2006-10-01

    Quality Director

    Brand:

    Electrical, automotive relays, MCB and MCCB short circuit breakers production (both domestic and industries, car’s relays)


    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


    Sonion Poland (Microtronic)

    Mierzyn (Szczecin, West Pomeranian Region)

    1998-11-02 >> 2005-08-01

    Head of Quality Assurance

    Brand: Medical Devices

    Electroacoustical micro receiver for Hearing Instruments

    Electret microphones

    Telecoils production


    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


    P.O.A.T Sztormland Sp. z o. o.

    Szczecin (West Pomeranian Region)

    1998-04-01 >> 1998-11-01

    Electric Tools Service Manager

    Brand: Household appliances


    Servicing small domestic machine, cost control

    Application design, selection and installation of micro-impact marking machines by the Spanish company Couth for the Szczecin Shipyard


    Autocomp Electronic Sp. z o. o.

    Szczecin (West Pomeranian Region)

    1997-03-01 >> 1998-04-01

    Design Engineer

    Brand: Military


    Integration and installation of a system of 4 RappHydema anchor winches, Brunvoll bow and stern thrusters and adjustable blades of the ship's two propellers into one main system for maintaining and stabilizing the position of the ORP Piast naval rescue ship.


    The project was carried out at the naval shipyard dock in Gdynia.


    It included:

    - installation of an integrated panel on the captain's bridge

    - connection of all executive devices to the main computer

    - conducting sea trials in the Bay of Gdańsk



    Consent for Recruitment Process

    I hereby give my consent for the processing of my personal data included in my job application for the purpose of the recruitment process in accordance with the General Data Protection Regulation (EU) 2016/679 (GDPR) and the Polish Personal Data Protection Act of 10 May 2018.

    Thank you for considering my application. I look forward to the possibility of an interview.

    Best regards,

                           Krzysztof Kucharski