Marcin Jadczak
Quality Engineer - Projects and Line Support @Abbott
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WORK HISTORY
Quality Engineer - Projects and Line Support @Abbott
Quality Engineering Line Support for Stent Delivery System manufacturing, solving and troubleshooting production line issues.•Deliver quality management in areas including implants, catheters, drug eluting stents, and final packing.•Incorporate standards of ISO 13485, ISO 14971, and 21 CFR 820 and ensure compliance. •Quality core team member for major cross site projects such as printing, electronic IFU, Brexit, etc.•PM for unplanned events and cross site projects such as rework and continued processing assessment, VMP consolidation, etc.•SME for nonconforming product disposition released in the field - assess stop ships, product escalations, health hazard escalations, and distributed product assessments.•Manage customer complaint exception (NCR) investigations, complaint trend monitoring and monthly Quality Data Review meetings with Management. •Contribute validation support for facilities, equipment, sterilization, new production line layouts, and DQ/IQ/OQ/PQ protocols/reports. •Complete Inspection Control Plan updates and FMEA\'s for major changes to processes, impact assessments for changes requests to determine direct impact to the functional area.•Investigate, review, and approve nonconforming material reports, change orders, equipment work orders, etc.•Operate as CAPA SME – review investigations completed by others and perform rubric scoring.•Implement corrective and preventive actions to problems and line improvement projects.•Manage updates and maintain product risk management files and site validation master plan documentation.•Use and implement SPC methods for process monitoring, create yearly product consumption reports.•Quality Forum owner – track department actions, project dashboard, upcoming changes and change requests.•Use SAP inventory system daily to track progress of production and remedies of errors.•Implemented sampling reduction for in-process pouch seal strength and oxygen content as part of Green Belt project (CIP ~$180k).
EDUCATION
Shipbuilding Technical College
Mechanic Technician, Construction of Ship Machinery and Equipment
Technological University Dublin
CPD diploma, Engineering Technical Management & Innovation
Politechnika Morska w Szczecinie
Honours Bachelor Degree - NFQ Level 8, Management and Production Engineering
SKILLS
ABOUT MARCIN JADCZAK
Accomplished Quality Engineer with 15 years of experience in key quality roles working for a leading global manufacturer in the Medical Device industry producing cutting-edge products within a culture dedicated to innovation. Proven ability to deliver critical expertise, thorough and compliant quality inspections, CAPA experience, plan development and analysis, data analytics and reporting, impact assessments, validation support, coaching to assist others with compliance, reporting to senior management, and other general compliance consulting. Collaborative team member and expert communicator with the ability to collaborate with individuals and groups across department lines, apply critical thinking and complex problem-solving, and consistently deliver results on-time and according to desired standards.
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