Paweł Barycza
Lider Jakosci
Solothurn,
zagranica
Doświadczenie zawodowe
Senior Compliance Engineer, SQ
Stryker
> Suppliers NC/CAPA coordination
> Single point of contact (SPOC) for one of the strategic suppliers
> Mentoring new employees in quality department
> Support and collaborate with RA on providing feedback to regulatory
> Leading cross functional teams to resolve quality issues relates to suppliers
> Indirect responsibility for training junior member stuff
> Leader of supplier certification project (Dock to stock)
> Monitoring of suppliers performance
> Suppliers rework request approval
> Coordinating across worldwide Stryker sites market complaints linked to suppliers (RC investigation, CAPA)
> Reviewing / approval of suppliers validation plan / reports
> Liaising supplier's inspection techniques with internal goods inwards department to reduce inspection/measurement bias
> Coordinating change control process for changes related with the suppliers
> NCRB/MRB (Material Review Board)
> Compiling Quality Agreements with the suppliers
> Coordinating Process / Products Specification with suppliers
> Working with DPMs, Back Order and other KPIs values to ensure high and on time supplier performance
> Responsible for SQ tasks in Manufacturing Transfer process and New Product Introduction
> Single point of contact (SPOC) for one of the strategic suppliers
> Mentoring new employees in quality department
> Support and collaborate with RA on providing feedback to regulatory
> Leading cross functional teams to resolve quality issues relates to suppliers
> Indirect responsibility for training junior member stuff
> Leader of supplier certification project (Dock to stock)
> Monitoring of suppliers performance
> Suppliers rework request approval
> Coordinating across worldwide Stryker sites market complaints linked to suppliers (RC investigation, CAPA)
> Reviewing / approval of suppliers validation plan / reports
> Liaising supplier's inspection techniques with internal goods inwards department to reduce inspection/measurement bias
> Coordinating change control process for changes related with the suppliers
> NCRB/MRB (Material Review Board)
> Compiling Quality Agreements with the suppliers
> Coordinating Process / Products Specification with suppliers
> Working with DPMs, Back Order and other KPIs values to ensure high and on time supplier performance
> Responsible for SQ tasks in Manufacturing Transfer process and New Product Introduction
Cell / NPI Quality Leader
Bespak
> Costumer complaints investigation (collaboration across departments)
> Working on projects with single and multiuse auto injector devices
> Reporting directly to senior management
> Suppliers management
> Support and collaborate with RA on providing feedback to regulatory
> Internal audits, GMP audits
> Strong working knowledge about Statistical Process Control (SPC, Minitab)
> Suppliers audits (completed lead auditor training by BSI)
> Implementation of the KPI
> Validation IQ, OQ, PQ of manufacturing equipment
> Validation of automated packaging line
> Leading CAPA activities
> Responsible for supervision of the quality team in production cell
> Quality leader for NPI projects
> NCR (Non Conformance Reports)
> Reviewing / managing Design History Files (DHF)
> Work with supply chain to ensure on schedule product delivery
> Communication with customers and suppliers
> Continues improvement
> FMEA, MSA,
> Quality release of the final product
> 8D report, Risk Assessment, Document Change Control
> ERP: SAP, FRACAS
> Working on projects with single and multiuse auto injector devices
> Reporting directly to senior management
> Suppliers management
> Support and collaborate with RA on providing feedback to regulatory
> Internal audits, GMP audits
> Strong working knowledge about Statistical Process Control (SPC, Minitab)
> Suppliers audits (completed lead auditor training by BSI)
> Implementation of the KPI
> Validation IQ, OQ, PQ of manufacturing equipment
> Validation of automated packaging line
> Leading CAPA activities
> Responsible for supervision of the quality team in production cell
> Quality leader for NPI projects
> NCR (Non Conformance Reports)
> Reviewing / managing Design History Files (DHF)
> Work with supply chain to ensure on schedule product delivery
> Communication with customers and suppliers
> Continues improvement
> FMEA, MSA,
> Quality release of the final product
> 8D report, Risk Assessment, Document Change Control
> ERP: SAP, FRACAS
Project Leader
Abbott / AbbVie
> Leader of Lean Six Sigma project with core team of: 6 cross functional individuals in different location worldwide
> Metrology Leader for implementation of the new revision of the medical device. This includes two different manufacturing sites with capability of components mixed together between sites.
> Metrology Leader for implementation of the new revision of the medical device. This includes two different manufacturing sites with capability of components mixed together between sites.
Quality Engineer
Westpharma
> Internal audits & monthly compliance audits (completed auditor training by SQA)
> Identification and qualification of the new suppliers of metrology systems
> Compiling reports based on Statistical Process Control (SPC)
> MSA
> Supervision of the calibration process of measurement equipment
> Work with Design & Engineering on new device introduction
> Development and validation of the new measurement systems
> DFM (design for manufacture & design for metrology)
> Managing cost reduction projects in quality lab
> FMEA
> 5Why / Fishbone root cause investigation
> MRR (material review report)
> Change request
> Risk Assessment, 5S projects
> CAPA (corrective and preventive actions)
> Cooperating with third party tool makers in designing & manufacturing of the new tools for plastic injection and metrology fixtures
> Coordinating First Article Inspection (FAIR)
> Supervising of the CMM operators
> FTIR (Infrared analysis (using Perkin Elmer Spectrum 100 Spectrometer) of the plastic resin
> Identification and qualification of the new suppliers of metrology systems
> Compiling reports based on Statistical Process Control (SPC)
> MSA
> Supervision of the calibration process of measurement equipment
> Work with Design & Engineering on new device introduction
> Development and validation of the new measurement systems
> DFM (design for manufacture & design for metrology)
> Managing cost reduction projects in quality lab
> FMEA
> 5Why / Fishbone root cause investigation
> MRR (material review report)
> Change request
> Risk Assessment, 5S projects
> CAPA (corrective and preventive actions)
> Cooperating with third party tool makers in designing & manufacturing of the new tools for plastic injection and metrology fixtures
> Coordinating First Article Inspection (FAIR)
> Supervising of the CMM operators
> FTIR (Infrared analysis (using Perkin Elmer Spectrum 100 Spectrometer) of the plastic resin
Szkolenia i kursy
Reading and understanding of the technical drawings by NPL (National Physic Laboratory, UK)
> FDA submission of medical devices training, Berlin 2016
> Lead Auditor training by BSI (Nov 2014)
> Internal auditor training by SQT, Dublin
> Project management training by SQT, Dublin
> Statistical Process Control training by SQT (FETAC certificate, Dublin)
> CMM programming training by Zeiss
> CMM programming training on the PC DMiS by Hexagon
> In house CMM programming training on the Studio Inspect
> MCosmos training by Mitutoyo, UK
> Presentation training
> FDA submission of medical devices training, Berlin 2016
> Lead Auditor training by BSI (Nov 2014)
> Internal auditor training by SQT, Dublin
> Project management training by SQT, Dublin
> Statistical Process Control training by SQT (FETAC certificate, Dublin)
> CMM programming training by Zeiss
> CMM programming training on the PC DMiS by Hexagon
> In house CMM programming training on the Studio Inspect
> MCosmos training by Mitutoyo, UK
> Presentation training
Specjalizacje
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