Paulina Jajczyk
Galway,Ireland
Summary
Dynamic Quality Engineer with a proven track record at Boston Scientific, leveraging Six Sigma and regulatory compliance expertise to drive continuous improvement initiatives. Adept at leading cross-functional teams and mentoring peers, I excel in product validation and quality assurance, ensuring patient safety and product excellence in a fast-paced environment.
Overview
14
14
years of professional experience
Work History
Sterilization Quality Engineer
Boston Scientific
Galway, Ireland
01.2023 - Current
- Responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- Performing problem solving and continuous improvement investigations
- Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality
- Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Contributing to relevant Communities of Practice regarding EO Sterilization with influence across multiple Boston Scientific divisions and departments.
- Lead or participate in projects to identify root cause and implement corrective and preventive actions.
- Responsible for understanding nonconformance scope, implementing product/process controls, and determining release criteria. Responsible for investigating nonconformances and writing required documentation.
- Collects and analyzes process defect data for product/process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s).
- Support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Supports Sterilization Validation and Requalification Activities for EO sterilization cycles
- Supports New Product Introduction for EO sterilization
- Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
- Conducting product and process nonconformance investigations and may include NCEP & CAPA ownership.
- Mentoring technicians and junior engineers and investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques.
- Ensures compliance with company quality policies and practices by participating in product and material reviews, assist in resolving problems related to the Manufacture, test, validation, and documentation.
- Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Collaborate cross-functionally with R&D, Quality, Regulatory Affairs, and Operations to ensure robust sterility assurance integrity.
Quality Technician Centralised Sterilization and Packaging
Boston Scientific
Galway
04.2021 - Current
- Ensuring compliance to all applicable regulatory standards (ISO/MDD) and current GMP procedures and practices
- Routing final functional testing, product release criteria testing/inspection and recording of test results
- Controlling of non-conforming product, knowledgeable on Risk Management, BSEN 14971 requirements
- Responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- Performing problem solving and continuous improvement investigations
- Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality
- Providing assistance and support to the Quality Engineering and Operations function
- Decision making ability coupled with the ability to work by my own initiative and with minimum supervision
- Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager as the final arbitrator on critical quality decisions.
- Good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives
Quality Controller - Product Release COVIDIEN Ventilator's PB980
Celestica
Galway
08.2020 - 03.2021
- Provide cross training to other employees and support training of new employees.
- Participating in root cause investigations alongside with quality/manufacturing core members.
- Continuous improvement in day-to-day manufacturing process with focus on quality.
- Creating and maintaining company quality documentation, which would include some copies of PHRs, rework logs and procedures that would be continuously changed and adapted for the need of customer.
- Providing validation activities on newly assigned product release data base system, reporting to IT personnel in case of any doubt in terms of good functionality and effectiveness of the system.
- Responsible for making a final call and judgement in terms of cosmetic defects, that in normal circumstances would not be acceptable, but because of the written agreement of the customer in circumstances of ongoing pandemic and high demand of ventilators.
Project Engineer
Allergan
Westport
01.2019 - 09.2019
- Pre-design projects of sterile equipment for aseptic processing for filling and packaging of biological injectable drug product for global market
- Clean and pack development activities for packaging
- Initiate new component requests and validation of equipment vendors for approval and placement onto Allergan's approved database to comply with ISO13485, ISO9001 and Quality System.
- Generated Purchase Orders for Global Engineering projects. Budget control. SAP management.
- Management of Change Control of quality production, manufacturing, and processing SOPs, etc.
- Administration of project team e.g., minute taking, scheduling of meetings, follow-up reports and key actions communicated to relevant parties and site management.
Production Supervisor, Quality Controller, Machine Operator
Hot Deep Galvanising Factory - Tadeusz Kunaj
Boguszyce
01.2012 - 01.2013
- Operating an automated rack electroplating machines
- Selecting electrical intensity and voltage suitable for various product type
- Programming of safe and optimal machine processing
- Performance testing for end-product Quality Control
- Maintaining detailed and accurate maintenance records and production documentation for audit inspection
- Operating electroplating waste treatment plant including emergency situations.
Education
Master of Science - End To End Sterility Assurance
Atlantic Technological University Galway
Galway12-2025
ME. Eng. (Hons) - Biomedical Engineering
NUI Galway
Galway01.2022
Higher Diploma - Design and Manufacture of Biopharmaceuticals
University College Cork
01.2021
B. Eng. (Hons) - Biomedical Engineering
NUI Galway
01.2020
Foundation Diploma - Engineering, Science and Technology
NUI Galway
01.2016
B.Sc. - Transport and Forwarding Specialist
Wroclaw School of Banking
Poland01.2013
FETEC Level 6 equivalent - Finance and Accountancy
Accountancy Vocational School in Twardogóra
Twardogóra, Poland01.2010
Skills
- Microsoft Office
- Quality assurance
- Regulatory compliance
- Team collaboration
- Product validation
- Project management
- Quality improvement plans
- 3D modelling
- Finite Element Analysis
- Computational Fluid Dynamics
- Experience of regulatory paths for FDA and European MDD
- ISO 11135
- ISO 13485
- ERP system
- AutoCAD
- EndNote
- Microsoft Teams
- Google Suites
- Leadership
- Teamwork
- Communication
- Flexibility
- Differential Scanning Calorimetry
- Tensile Testing
- Light Microscopy
- Scanning Electron Microscopy
- Free Amines Quantification
- Histology
- Cell culturing
- Manufacturing of Monoclonal Antibodies
- Technical documentation
Emails
- P.jajczyk1990@gmail.com
- Paulina.Jajczyk@bsci.com
Languages
- English
- Polish
References
- Julian Drapiewski, Director Wild Goose Enviro Ltd., (+353 86 8185188), jdrapiewski@hotmail.com
- Paul Moody, Director Global Engineering Projects Allergan Pharmaceutical, (+353 87 2489095), Moody_Paul@allergan.com
- Thomas Kelly, Associate Director Engineering AbbVie, (+353 87 6407673), Kelly_Thomas@allergan.com
- Samuel Nolan, Sr Quality Engineer Celestica, (+353 87 7378184), snolan@celestica.com
- Pat Murphy, Quality Manager Celestica, (+353 86 8561684), pamurphy@celestica.com
- Liam Whelan, Quality Technician Celestica, (+353 87 9017013), liamwh@celestica.com
- Susan Ryan, Sr Quality Engineer CSP Boston Scientific, (+353 91 406019), susan.ryan2@bsci.com
Hobbies and Interests
- Crafting - Cross stitch and Crochet
- Farming
- 3D Modelling
- Motorisation
Skills Profile
As a Shift Supervisor, responsible for driving the work according to other workers' abilities. As Engineering Technician, I took ownership in several areas: vendor set-up and trolley design development, volume jig development, clean room classification and analysing technical drawings., I pride myself on working well with a wide range of internal and external personnel, organising meetings and online conference calls with vendors and working closely with the Quality Department in terms of clean room classification., Day-to-day communication with key project team members and other necessary personnel across the company, e.g. Operations, Finance and Manufacturing and organising meetings with vendors and external suppliers., Ability to plan and prioritise, anticipate, and actively adapt working schedule to the changing demands as role/project progresses. Assist other engineers with prioritised meetings e.g. risk assessments workshops or incoming deliveries of important machinery for project needs.
Activities
- 3D Modelling - Inventor Professional 2016, Generation of hip replacement portfolio, Jig design for syringe inspection
- FEA Analysis - ABAQUS, Stent fatigue testing, Goodman Analysis
- NUI Galway/UCC Laboratory - soft tissue, biomaterial testing, Differential Scanning Calorimetry (DSC), Tensile Testing - Zwick/Roell tensile testing - 10N load cell, Light Microscopy, Scanning Electron Microscopy (SEM), Free Amines Quantification - centrifuge, etc., Histology and cell culturing, Manufacturing of Monoclonal Antibodies
Languages
Polish
First Language
English
Proficient (C2)
C2
References
References available upon request.
Timeline
Sterilization Quality Engineer
Boston Scientific
01.2023 - Current
Quality Technician Centralised Sterilization and Packaging
Boston Scientific
04.2021 - Current
Quality Controller - Product Release COVIDIEN Ventilator's PB980
Celestica
08.2020 - 03.2021
Project Engineer
Allergan
01.2019 - 09.2019
Production Supervisor, Quality Controller, Machine Operator
Hot Deep Galvanising Factory - Tadeusz Kunaj
01.2012 - 01.2013
Master of Science - End To End Sterility Assurance
Atlantic Technological University Galway
ME. Eng. (Hons) - Biomedical Engineering
NUI Galway
Higher Diploma - Design and Manufacture of Biopharmaceuticals
University College Cork
B. Eng. (Hons) - Biomedical Engineering
NUI Galway
Foundation Diploma - Engineering, Science and Technology
NUI Galway
B.Sc. - Transport and Forwarding Specialist
Wroclaw School of Banking
FETEC Level 6 equivalent - Finance and Accountancy
Accountancy Vocational School in Twardogóra