Scott Peloquin

Experience

• 

  CarboMedics

  Jan 1990 - Oct 2008

  Work with company field representatives/distributors and hospital customers to collect information surrounding field events and complaints with CarboMedics Inc. products.Properly maintain filed event / complaint files and database to ensure files are ready for audits and everyday use.Perform incoming inspection, decontamination, photography, microscopy, and disassemble of returned product and explant devices to quantify the expressed complaint.Assure all of the above is performed in compliance with internal policies and procedures and with recognized domestic and international regulations regarding event handling and device reporting (e.g. FDA, MDR, EEA DVR, etc.) to maintain internal and external audit readiness.Perform tests (including validations) designed by Quality or Engineering to evaluate inspection methods and/or to determine capability of equipment and processes. Present data reported to Quality or Engineering on such activities. Acquire, analyze, and report data.Assist Regulatory Affairs department with creating FDA submissions, reviewing marketing brochures and logistical support of documentation handling. Show less Oversaw and coordinated the execution of test plans and writing test reports in compliance with FDA, ISO, and QSR regulations and guidelines for improvement of product or processes.Coordinated with project teams and team leaders to design, change, or implement inspection, manufacturing, and computer systems and procedures.Provide technical support and solutions during problem investigations for team communication and research.Write reports on non-conforming items, i.e. Discrepant Material Reports to comply with FDA requirements.Assist with completing current production needs to meet the planned goals for the area.Prioritized Receiving Inspection functions through weekly staff meetings and production reports to ensure efficiency, communication, and quality goals.Prioritized the needs and requests of internal customers, with current workloads, manpower, and ability so that production and quality goals were met within budget requirements.Maintained all communications between the professional staff and Receiving Inspection personnel to ensure projects and workloads were appropriately timed.Formulated and implemented solutions to and for the Receiving Inspection systems, products, and personnel to improve the cost, function, and quality of the area.Created and implemented new inspection procedures and policies, to reduce cost and improve performance.Designed the Receiving Inspection computer system, which includes: Assignment of controlled material lot numbers, tracking of Shelf Life, Bond, Report design, Test tracking, and Supplier History Maintenance to move from a manual documentation system to an electronic database.Responsible for all training concerning mechanical, visual and functional inspection to ensure procedural compliance.Chaired quarterly meetings with upper management to review supplier performance against internal expectations to help maintain supplier quality levels and achieve utilize SPC trending in their performance. Show less

  • Sr. Reliability Technician

    Jan 2005 - Oct 2008

  • QC Technician

    Jan 1990 - Jan 2005
• 

  Thermo Fisher Scientific

  Jan 2011 - now

  • Establish Supplier Quality fundamentals such as supplier metrics & scorecards, supplier business reviews, and issue tracking and resolution enabling KPI leadership for the function. • Facilitate forums with appropriate technical expertise when root cause corrective action (RCCA) is required on escalated division level issues. Drive teams and suppliers to appropriate corrective actions and problem resolution. • Develop and maintain successful relationship with suppliers, design and development teams, and sourcing teams to continually improve cross department collaboration.• Lead production part approval process (PPAP) activities on new product development & introduction (NPDI) teams. Ensure adequate supplier control plans are defined and deliverables are executed, aiding in continual improvement of supplier quality.• Provide support for the implementation of supplier quality programs to business unit supplier quality engineers. • Ensure First Article Inspection requirements are defined and executed by appropriate personnel. Show less Develops and revises procedures and forms for ISO Quality System.Establishes, monitors, and presents quality metrics for product improvement teams; communicating potential key product quality issues to management; reviewing and approving engineering change requests (ECRs); and updating Quality Assurance Procedures (QAPs).Provides QA oversight and support for assigned production work cells. Working with and in coordination with operators, manufacturing engineering and management insures daily review of the product quality data to assess work cell performance and identify and drive needed change.Represents Quality on new product development teams. This involves defining deliverables which support definition of next phase plans, leading FMEA activities, auditing of new suppliers, development of QAPs, and ensuring the product developed meets customer expectations through the development and execution of process I product validation plans and control plans.Provides Incoming Receiving and First Article Inspection QE support to insure that output meets the needs of production to the work cell level and new product development teams.Uses statistical techniques such as DOE, SPC, Gage R&R, and capability studies to improvedesigns, analyze problems and monitor processes.Provides MRB support. This involves researching and dispositioning non-conforming material, reviewing dock-to-stock status and adjusting as required, and initiating product stock checks when necessary.Provides technical expertise in root cause analysis and development of corrective actions toQuality problems where little precedence has been established and innovative solutions may be required.Performs internal quality audits.Teams with Purchasing to insure timely execution of the Supplier Scorecard program. Performs training on Quality Systems to Quality Engineers, Quality Control Inspectors andother employees, engineers and managers.List of other duties provided upon request. Show less

  • Division Senior Manager Supplier Quality

    Jun 2022 - now

  • Division Product Quality Program Manager

    Mar 2019 - now

  • Supplier Quality Engineer, CMD Division

    Sept 2018 - now

  • Senior Quality Engineer

    Jan 2011 - now