Matthew Taylor Email and Phone Number
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Regulatory: 510(k), Quality System Regulation (QSR), Part 820, Medical Device Reporting (MDR), Complaint Handling, HIPAA, Hazard Analysis. Software: Team Foundation Server (TFS), Waterfall, Rational Unified Process (RUP), Agile, Test Driven Development, Release Criteria Process. Quality Assurance: ISO 9001, Lean Six Sigma, DMAIC, Reliability Improvement, Validation, Verification, Mean Time to Failure (MTTF), Process DevelopmentLean Six Sigma Black Belt, ASQ Certified Quality Engineer, ASQ Certified Manager of Quality/Organizational ExcellenceSpecialties: Quality System Development and Implementation, Process Development and Implementation, Process Improvement, Strategic Planning, Hardware/Software Test Management, Statistical Process Control, ISO Certification, Supplier Assessment, Lean Six Sigma.
Prototest
View- Website:
- prototest.com
- Employees:
- 8
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PrototestOak Harbor, Wa, Us
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RetiredCuattro Medical, Llc Jul 2023 - PresentGolden, Colorado, Us -
Sr. Compliance And Quality Consultant, Project LeadMaetrics, Llc May 2013 - Sep 2014Monroeville, Pa, Us• Project Lead for CAPA team members with respect to effectiveness verification/monitoring• Remediation efforts, to ensure compliance with 21 CFR parts 11, 803, 806, 820 & ISO 13485: 2003 quality systems • Support CAPA teams with problem solving, including Root Cause Analysis efforts• Verification of completeness & effectiveness for client CAPA activities, including EtQ CAPA objective evidence elements -
PrincipalLemast Consulting Oct 2008 - May 2013(Contract to Cuattro, LLC as Director, Quality Assurance /Regulatory Affairs) (2008-2010)* Quality System development and implementation to 21CFR 820, for medical device manufacturer* Performed validation and verification planning for digital radiography device, including Hazard Analysis. Included software test plan and execution to support release of device as a member of the agile development team* Preparation and submission of premarket clearance documentation, 510(k), for new medical device* Respond to FDA Information Requests leading to successful clearance for new medical device
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Director, Qa & RaCuattro Nov 2008 - Sep 2012• Led company through successful Level II QSIT audit• Established regulatory documentation required for International Medical Device sales/delivery* Direct process development and implementation, quality system as well as software test processes* Compliance officer for corporation (HIPAA, QSR, GMP)* Prepare documentation to support submission of premarket clearance documentation, 510(k), for new medical device* Prepare documentation for clinical trial, to support premarket clearance submission
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ConsultantPrototest Jun 2008 - Sep 2008Centennial, Co, UsSoftware Verification & Validation Planning, under contract to Covidien
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Vice President, Quality AssuranceOn Command Mar 2001 - Jan 2008UsProvided strategic planning and direction for Operations and Engineering Quality groups.Directed manufacturing, software and IT quality assurance professionals located in San Jose, California and Denver, Colorado. Managed $2.2 million budget and 21 employeesEnsured products met or exceeded customer expectationso Developed and implemented New Product Development processes, Waterfall, Agile and Rational Unified Process (RUP) to support changing organizational structureo Performed Corrective Action / Preventive Action activities on computer hardware components (Hard Drives, RAM, PCBs)o Led reliability initiatives that reduced server failure rate 74% over a three-year period, while increasing mean time to first failure on Video On Demand product 155%, over the same periodo Planned, directed and championed a reliability improvement program that reduced client computer off-line rate 78%, by working with five independent operations groups (development engineering, sustaining engineering, video operations, quality assurance and manufacturing) -
Director, Qa & RaMedtrac Technologies Apr 1998 - Mar 2001Directed and oversaw all facets of operations, procurement, engineering, manufacturing, warehouse, and IT infrastructure. Maintained quality system and ensured full compliance with FDA requirements. Prepared all regulatory filings, monitored process validation, performed packaging testing, conducted complaint analysis and qualified vendors.o Timely relocation of entire manufacturing and warehouse facility, planning and executing each step, start to finisho Supported effective and efficient facility operations by developing and maintaining documentation for engineering drawings and procedureso Provided for data collection to support a significant clinical trial by a major manufacturer of handheld asthma inhalers, enabling release of customer’s new product with proven efficacy
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Manager, Qa & RaLabac Systems May 1995 - Apr 1998Developed, implemented and managed quality assurance systems to ensure compliance with FDA quality system requirements. Managed team of up to 11 in three departments: receiving, in-process and final inspectiono Addressed and resolved all issues detailed in a prior FDA Notice of Adverse Findings, ensuring business continuityo Developed and implemented 21CFR820 compliant quality systemo Performed Corrective /Preventive Action activities on various wheelchair components to support product complaint and MDRso Facilitated successful integration of LaBac seating system to Everest Jennings wheelchair system after a merger of the two companies by integrating both quality systems. Accomplished with working sessions at facilities in Colorado and Canada
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Quality Control ManagerMedex Nov 1994 - May 1995Manage Receiving, In-process, and Final Inspection departments for infusion pump manufacturer.o Assure timely release of product (both hardware and sterile product).o Prepared Inspection department for corporate relocation to Georgia (hardware) and Ohio (sterile disposables
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Sr. Quality EngineerFischer Imaging Jan 1991 - Sep 1994Denver, Co, UsQuality Engineering support for x-ray productso Inside liaison for company’s largest OEM customer (Varian Oncology)o Led ISO 9001 certification effort, certification received ahead of schedule and under budgeto Led development of service-to-failure reporting database for Corrective Action / Preventive Action purposeso Software validation testing for computer tomography simulator -
Manager, Qa & RaMountain Medical Equipment Aug 1984 - Jan 1991Assure corporate compliance with Good Manufacturing Practices, 21CFR820o Developed and taught courses on Statistical Process Control (SPC) o Implemented SPC in inspection and engineering disciplineso Developed supplier audit process and performed supplier audits for key suppliers
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Production ManagerElectromedics Jul 1981 - Aug 1984Manage blood pressure transducer production lineo Developed disposable fiber optic physiological transducero Production engineering support for physiological pressure transducero Production engineering support for sterile disposable products
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Process EngineerEaton/Ailtech Apr 1972 - Jul 1981Engineering support for weldable strain gauge product lineSustaining engineering for physiological pressure transducer productso Led design improvements (manufacturability and reliability) for disposable fluid isolator for physiological transducero Led design improvements (manufacturability and reliability) for pressure relief products for physiological transducer
Matthew Taylor Skills
Matthew Taylor Education Details
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Ssd GlobalLean Six Sigma Black Belt Certification -
Colorado Christian UniversityEmphasis In Human Resources
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California State University-Dominguez HillsPhilosophy
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Rio Hondo CollegePhilosophy
Frequently Asked Questions about Matthew Taylor
What company does Matthew Taylor work for?
Matthew Taylor works for Prototest
What is Matthew Taylor's role at the current company?
Matthew Taylor's current role is Director, Quality Assurance / Regulatory at Cuattro.
What is Matthew Taylor's email address?
Matthew Taylor's email address is mt****@****ics.com
What is Matthew Taylor's direct phone number?
Matthew Taylor's direct phone number is +131296*****
What schools did Matthew Taylor attend?
Matthew Taylor attended Ssd Global, Colorado Christian University, California State University-Dominguez Hills, Rio Hondo College.
What skills is Matthew Taylor known for?
Matthew Taylor has skills like Quality Assurance, Quality System, Process Improvement, Fda, Six Sigma, Medical Devices, Testing, Spc, Software Documentation, Validation, Iso, Quality Control.
Who are Matthew Taylor's colleagues?
Matthew Taylor's colleagues are Mohamad Malik Malik, Melanie Hertan, Jose Sueyras.
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