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 / QMS Management

Supplier Quality Management

Leangineering

Six Sigma

Project Management

Software Validation

AI Model 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

Systems

MasterControl Classic20

Axapta

SAP

Creo

Windchill

Coding

Python

SQL

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 leader with a rare blend of technical depth, managerial experience, and forward-looking digital competence. As an effective, charismatic, and empathetic leader, I am deeply committed to my team's well-being and growth, ensuring we consistently deliver bold, measurable results. My strength lies in driving operational maturity across highly regulated environments, including the Medical Device, Automotive, and Energy sectors. I courageously pioneer the adoption of modern tools and solutions—merging advanced manufacturing methodologies with data-driven AI frameworks—to transform daily operations, elevate team management, and build robust, scalable quality systems.

Core Competencies & Expertise


Quality & Validation Leadership

• Full Quality Department & Integrated Systems Management 

• Elevating Quality Department Maturity & Operational Excellence

• Software, Equipment & Process Validation

• AI Models Validation, Test Method
• Automated Inspection Systems (ML)
• QMS (ISO 9001, 13485, MDSAP)
• FDA 21 CFR Part 820 & Part 11 ERES


Project & Change Management

• Cross-functional NPI Projects
• Machine Transfers & Process Optimization
• Prince2 Methodology
• CTQ Flowdown

• Data Analysis (Python)

Lean & Advanced Manufacturing

• Lean Management & Six Sigma
• Kaizen, SMED, TPM, 6S
• Quick Response Manufacturing (QRM)
• Value Stream Mapping (VSM) & Optimization


Digital Transformation & AI

• Digital Quality Inspection Plans (DQIP)
• Python & Azure DevOps
• Machine Learning in QA (QMS, Validation)
• AI-driven Risk Assessment


Risk Management

• Advanced Risk Analysis Tools for Medical & Pharma (incl. GxP, CSV, CSA and AI Computer System Validation - AICSV, GAMP 5 Second Edition) 

• Modern Manufacturing Risk Management (incl. FMEA, PFMEA, DFMEA & Control Plans)

• Critical Paths / Test Scenarios (Risked-based)

• Functional Paths / Test Scenarios

• Heuristic / Exploratory Tests (Risk-driven)


Career Highlights


Global Validation

QA Specialist

Radiometer Solutions


Global Quality & Validation Engineering (Radiometer Solutions)

Global Validation Leadership: Driving and executing comprehensive global validation streams within a highly regulated Medical Device environment. Specializing in end-to-end software, equipment, and process validations, ensuring strict adherence to GAMP 5, ISO 13485, MDSAP, and FDA 21 CFR Part 820 & Part 11 (ERES) standards.


Advanced Manufacturing QA: Leading complex validation protocols for critical manufacturing processes, including Injection Molding machines and molded parts, test methods, laser welding, and automated test stations. Overseeing Engineering Changes and maintaining rigorous Quality Specifications.


Next-Gen Inspection & Automation: Managing the validation and quality control of Automatic Optical Inspection (AOI) systems for planar electrochemical sensors. Actively integrating modern digital tools, utilizing Python and AI-driven methodologies (such as Machine Learning concepts) to optimize risk assessment, automate statistical reporting (Pareto tables for Engineering Changes), and enhance overall validation efficiency.

Risk-Based Validation Strategy: Designing and executing robust Operational Qualification (OQ) frameworks, utilizing risk-based critical and functional paths, alongside risk-driven heuristic/exploratory testing scenarios to ensure the highest product safety and reliability.


Complex QA & QMS Mgt.

QA Manager

DGS Diagnostics & Tyco Electronics


Plant Quality Leadership & Strategic Operations (DGS Diagnostics & Tyco Electronics)

Executive Quality Management: Directed full-scale plant Quality departments across the Medical Device and Energy sectors, reporting directly to VP and EMEA Quality Directors. Managed quality budgets, established KPI frameworks, and led high-performing teams through complex business and operational challenges.


Advanced QMS & Global Compliance: Steered comprehensive Quality Management Systems, overseeing rigorous medical audits, internal QMS, and complex deviation approval processes. Directed compliance documentation (CoC, TR, COO) and First Article Approval Reports (FAAR) at both local and EMEA levels.


Operational Excellence & Digitalization: Pioneered the implementation of Digital Quality Inspection Plans (DQIP) and drove aggressive Cost of Poor Quality (COPQ) initiatives, including dedicated scrap reduction projects. Utilized advanced 8D methodology, Daily Gemba Walks, and Process FMEA to resolve critical production and customer issues.

Cross-Functional Synergy & Supplier Development: Fostered seamless collaboration between R&D, Production, Logistics, and Customer Service to enhance the overall Customer Experience. Led strategic supplier development programs, managed inbound/outbound quality, and translated product requirements into robust CTQ flowdowns.

Automotive Transfers (Project Manager)

Borgwarner

(AE Group)


Industrial Project Management & Automotive Validation (BorgWarner / AE Group)


Strategic Technology Transfer & Commissioning: Directed the complex, cross-border transfer, installation, and full-scale commissioning of high-value manufacturing assets. Successfully launched advanced Heller CNC machining centers and automated High-Pressure Deburring Robotic Washers (Silberhorn, Semmelroth) for VW/Audi transmission components.


Automotive Compliance & PPAP Execution: Ensured rigorous adherence to stringent automotive industry standards by maintaining and executing critical Production Part Approval Process (PPAP) and Machine Capability (MFU) documentation throughout the equipment lifecycle.


Comprehensive Systems Validation: Led end-to-end validation protocols covering manufacturing software, injection molding machinery, molded parts, and complex test stations. Actively managed Engineering Changes (EC) and defined strict quality specifications to ensure defect-free production of precision aluminum housings.

Robotics & Logistics

Operational & Change Manager

Amazon Robotics


Operations, Change & Facility Management (Amazon Robotics Fulfillment Center)


Strategic Change & Lean Logistics: Spearheaded cross-functional change management processes and Lean logistics projects within a high-paced, advanced e-commerce robotics environment. Led continuous improvement initiatives, "Lesson Learned" workshops, and structured Kaizen/5S events to optimize fulfillment center operations.


Large-Scale Facility & Financial Management: Executed comprehensive facility management, including building maintenance leadership, complex bus transportation coordination (utilization management), and canteen operations for a massive workforce. Directly managed operational (OPEX) budgets and Capital Expenditure requests (CAPEX CARs).


Performance Analytics & Safety Compliance: Supervised critical operational KPI dashboards to monitor site performance. Championed workplace safety by conducting rigorous Safety Housekeeping audits, ensuring a secure and compliant high-performance environment.

QA & Lean Transformation & Cost KPI

Head of Quality Assurance,

QA Manager, QA Director, Lean Manager

Sonion, DGS Poland, Electrolux, GE Power Controls


Executive Leadership Experience (Quality & Lean Management)


Quality & Operations Leadership (DGS Diagnostics | Tyco Electronics | Electrolux | GE Power Controls | Sonion):Consistently led, scaled, and managed full Quality departments and integrated systems across multi-site manufacturing operations. Demonstrated strong capability in managing quality budgets, optimizing CAPEX/OPEX, and driving In-House Quality. Excelled in handling international customer claims, leading audits (including UL and medical audits), and implementing robust QMS frameworks (ISO 9001, 14000, 13485, VDE).


Continuous Improvement & Lean Culture (DGS Poland - Oticon | Amazon Robotics | Electrolux):Championed deep Lean transformations across massive manufacturing campuses and advanced robotics environments. Founded internal training programs (e.g., BTE Lean Academy) to foster a culture of continuous improvement. Expertly utilized Lean methodologies (Kaizen, 5S/5S Plus, VSM, TPM, SMED, QRM) to optimize assembly layouts, balance production lines, and drive Six Sigma defect reduction projects.


Risk Analysis & Cost of Poor Quality (COPQ) Management (All management roles):Proven track record of utilizing modern manufacturing risk management tools (FMEA, PFMEA, DFMEA, Control Plans) and driving cost reduction initiatives. Successfully implemented CTQ/CTP flowdowns, conducted Gage R&R analyses, designed testing equipment, and led supplier development programs to systematically reduce COPQ and improve operational maturity.

Early Integration

Design Engineer

Autocomp Electronic

Naval Engineering & Complex Systems Integration (Autocomp Electronic)


Advanced Systems Integration: Engineered and successfully integrated a highly complex, centralized positioning and stabilization system for the ORP Piast military naval rescue ship. Synchronized multiple heavy maritime mechanisms, including RappHydema anchor winches, Brunvoll thrusters, and adjustable propeller blades.


Hardware Automation & Control Design: Directed the physical installation of the integrated command panel on the captain's bridge. Ensured seamless hardware-to-software communication by connecting all executive mechanical devices to the ship's main operational computer.


End-to-End Commissioning & Validation: Managed full-scale project implementation directly at the naval shipyard dock in Gdynia. Planned and led rigorous sea trials in the Bay of Gdańsk to validate system performance, safety compliance, and operational reliability under real-world maritime conditions.


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