John Clarke

Experience

• 

  New England Event Services

  Feb 2005 - Oct 2009

  Team Manager
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  Warwick Mills Inc

  Oct 2009 - Jan 2013

  Project Manager/Technical Lead

  Team leader for new product development and government sub-contract research efforts.Responsible for project budget, planning, presentation writing, report writing, and auditing.Engineering support for manufacturing scale up regarding anti-microbial coatings, and string knit garment production.Efficiency auditor for manufacturing processes post technical transfer.QC test support.Supplier selection, auditing and management.

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  Radius Innovation & Development

  Jan 2013 - Aug 2017

  Identify, review and interpret industry, regulatory, environmental, mechanical and electrical standards and requirements. Participate in the development and review of test strategies, product requirements and design inputs based on project phase. Develop, manage and execute test project documentation including, but not limited to test plans, methods, data, data analysis, data audit, data presentations and reports for concept, prototype (engineering qualification) and pilot (design verification) testing. Select / design, procure and troubleshoot test equipment and fixtures. Develop, document and validate test methods. Identify, qualify and manage external test suppliers. Lead root cause analysis of test failures. Participate in design inputs and design outputs reviews. Collect and manage content of project design history files (DHF). Participate in quality management system processes and documentation including, but not limited to training records, calibration records, supplier records, engineering change orders (ECO), non-conforming material review (NCMR), corrective and preventative actions (CAPA) and document retention schedules. Develop site-level quality management system procedures and templates. Lead internal audits and support notified body / ISO registrar and customer audits of the quality management system. Provide guidance to project teams and customers on compliance with the quality management system. Develop, manage and execute processes and documentation for receipt, acceptance, assembly and release of prototype/pilot materials for assembly by Radius. Complete and document prototype/pilot assembly, release testing and distribution to supplier and customers. Participation in project planning through proposal development and review. Show less

  • Quality Engineer, Quality and Implementation

    Nov 2016 - Aug 2017

  • Test Engineer, Quality and Implementation

    Nov 2014 - Nov 2016

  • Contractor

    Jan 2013 - Nov 2014
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  Teleflex Medical OEM

  Aug 2017 - Dec 2018

  •Nonconformance (NC) and CAPA processing - lead quality activities with respect to Value Stream Material Review Board coordination; inspection methods, NC containment/correction/closure and CAPAs; and drive improvement through analysis of trend data. •Customer Complaint Investigations - Primary investigator and facilitator for Value Stream complaint investigation, confirmation and corrective actions. Act as primary customer contact on complaint communications. Drive improvement based on trends.•Process Validations - guide and review protocol development, validation implementation and report review an acceptance;•Quality & Cost Improvement Projects - lead and participate on key short term projects on product or process improvements;•Production & Process Controls - review, change and approve Manufacturing Procedures; Test Method validations; Quality Inspection Plans and Process run sheets •Auditing - routinely perform internal and process related audits. Participate in vendor audits if necessary. Support the Back Room during FDA and Notified Body audits. •Documentation Control - perform Customer Product Specification reviews. Initiate Engineering Change Notices and review/approve as needed.•Training - Perform QA training certifications on new Production operators.•Support Engineering with New Product Development with quality planning, risk evaluation and validation. •Perform any additional QA tasks, as assigned by QA Manager or Plant Manager. Show less Execution of daily Quality Assurance activities associated with a designated manufacturing operation. Assist with quality and productivity improvement efforts when identified. Assist with nonconformance (product or process) process including immediate actions, containment, root cause investigation; corrective action and disposition of nonconforming materials during Material Review Board (MRB) meetings. Assist with Corrective and Preventive Action (CAPA) program. This includes leading or supporting a CAPA through each phase of process – Root Cause investigation; corrective action planning; corrective action implementation; verification of effectiveness (VOE) planning; VOE completion and CAPA closure. Support the Customer Complaint process through primary investigation activities; inspection of complaint samples; review of manufacturing and inspection documentation; and development of corrective actions on confirmed complaints. Development and revision of Quality System procedures, inspection plans, test methods and work instructions. Participate in Internal Process audits and support external customer or Notified Body audits, as needed. Support and participate in Supplier audits. Work closely with manufacturing to support process operations and testing requirements. Work closely with new product development engineers and supports protocol, procedure, and specification development. Implement test methodologies. Assist with completion of process validations or test method validations. Develops, maintains and approves Inspection Procedures and Test Methods and provides training as required. Handling and resolving supplier quality issues (non-conformances and Supplier Corrective Actions). Show less

  • Quality Engineer

    Feb 2018 - Dec 2018

  • Associate Quality Engineer

    Aug 2017 - Feb 2018
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  Abbott

  Jan 2019 - Oct 2022

  Quality Engineer II
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  Cogmedix

  Oct 2022 - now

  • Compliance Manager

    May 2023 - now

  • Senior Compliance Engineer

    Oct 2022 - May 2023