MATTHEW TURANT
Summary
I am a high energy and results oriented professional who provides a good balance between Operations and Quality Assurance. My objectives are to consistently exceed expectations and deliver on company metrics while improving the quality of products. My focus is to accomplish tasks everyday that help strengthen the company's Quality Management System. I accomplish this through team development and optimization of the resources available. I am at my best when I am able to think strategically with peers in cross functional departments to accomplish business objectives.
Overview
22
22
years of professional experience
1
1
Certificate
Work History
Quality Assurance Manager
Epredia
09.2017 - 09.2023
- Representative and PRRC representative for ISO2016 and FDA 21CFR Part 820, GMP compliant facility
- Successfully led the Portsmouth site through the ISO 13485:2016 recertification
- Manager of 15 employees in Cytology and Histology Lab, QC Final Inspection, Document Control and Quality Engineering
- Direct interface with all internal & external customers on a variety of issues ranging from new product development to product transfers and customer complaint management
- Responsible for leading a team that accomplished ~40% customer complaint reduction between 2019 and 2023
- Managed all validation aspects of Coverglass product transfer from the Unite States to Germany
- Lead auditor and manager of site auditing program under our 14791:2016 Risk Management process
- Successfully managed ERP system implementation; JD Edwards to SAP
- Successfully implemented new document control & training modules in Veeva Systems
- Successfully completed IVDR / Technical file remediation project for all microscope slides sold in the EU
- Manager of all aspects of monthly scorecard and quarterly management/business reviews
- Experienced user of QMS software- Master Control, TrackWise Digital, Entropy and Veeva Vault
- Collaborated with cross-functional teams to develop and implement process and system improvements.
- Successfully led a company initiative to migrate 900+ documents from Entropy to Veeva Vault.
- Performed root cause analysis to identify and resolve quality issues and defects.
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Investigated customer complaints and performed corrective actions to resolve quality issues.
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
- Conducted risk assessments to identify and mitigate potential quality issues.
Quality Assurance Engineer, • Lead Auditor
Thermo Fisher Scientific
01.2011 - 08.2017
- Audited all QMS documents to ISO 13485:2016 and 21CFR 820 requirements for FDA class 1 microscope slides
- Developed MRB nonconformance process for the site
- Investigated of hundreds of customer complaints related to diagnostic microscope product line
- Performed root cause and corrective actions using A3, Fish Bone and why quality tools
- Worked with project team to implement ISO 13485:2016 at the Portsmouth site
- Traveled domestically and internationally to support internal and external customers
- CAPA program lead investigator for Portsmouth site
Quality Assurance Engineer
Dionex Corporation
03.2010 - 01.2011
- Responsible for maintaining the QMS in accordance with ISO13485 and ISO 9001 for
- FDA class II medical device kits
- Managed the product complaint handling system to investigate, track and trend complaints and recommend corrective actions
- Evaluated complaints to comply with appropriate Health Canada -MDR/Vigilance requirements, conducted monthly complaint meetings and maintain all performance metrics as required by our QMS
- Perform internal and external audits to assess compliance with the Quality System
- Responsible for the review and QA approval of engineering change order requests
- Assisted in management review presentation for CAPA, SCAR and complaint metrics to upper management
- Initiated and participated in resolution of non conforming material
- Responsible for final product inspection and release of electrochemical detectors
- Supervised multiple direct reports in the Quality Control and Incoming Inspection departments
- Responsible for calibration, value assignment and batch release of FDA class II blood lead sensors for LeadCare I and II product lines
- Prepared engineering change orders, monthly inspection reports, non conforming material reports, certificates of analysis, and employee reviews
- Updated (KPI) Key Performance Indicator reports for management review
- Reviewed all in-process and final inspection test data for reagents, cells and HPLC instruments before releasing to stock
- Composed test protocols and worked as part of a team to validate new electrochemical cells and test equipment
- Composed and finalized corrective and preventative action plans
- Responsible for testing and reporting CDC, PA, NYS, and BioRad blood lead proficiency results.
Quality Assurance Supervisor
Dionex Corporation
01.2007 - 03.2010
- Supervised 5 direct reports in Quality Control and Incoming Inspection departments
- Responsible for calibration, value assignment and batch release of FDA class II blood lead sensors for LeadCare product lines
- Prepared engineering change orders, monthly inspection reports, non-conforming material reports, certificates of analysis, and employee reviews
- Updated (KPI) Key Performance Indicator reports for management review
- Reviewed all in-process and final inspection test data for reagents, cells and HPLC instruments before releasing to stock
- Revised QC test and calibration standard operating procedures for clarity, accuracy and efficiency
- Helped develop and oversee a department wide preventative maintenance and calibration program
- Composed and finalized corrective and preventative action plans
- Responsible for testing and reporting CDC, PA, NYS, and BioRad blood lead proficiency results.
Quality Control Technician II
ESA Biosciences
05.2001 - 12.2006
- Responsibilities included performing quality control tests of reagents, biomedical instruments,electrodes, cells and sensors
- Work involved setting up and running HPLC instruments and bloodlead analyzers
- Performed investigative studies of production non conformities and field complaints
- Responsibilities also included expiration date and various sensor studies overseen bymanufacturing management
- Managed QC department preventative maintenance and calibration system
Education
Bachelor of Science - Environmental Conservation/Affairs, Community Development
University of New Hampshire
1999
Skills
- Knowledge of 13485 Quality Management Systems
- Complaint Management
- CAPA Manager
- Supplier Quality
- 13485 Lead Auditor
- Risk Management Representative
- Site PRRC (regulatory Responsibility)
- Current Good Manufacturing Practices (CGMP)
- Continuous Improvements Project Champion
Certification
- PPI Process Champion and Facilitator - 2013
- Customer Allegiance Award Winner, Thermo Fisher Scientific - 2014
- BSI Trained ISO 13495 Lead Auditor
- Developing Emerging Leaders Program 2016
- 4I- Involvement Award Nominee- Thermo Fisher 2017
- ISO 14971 Risk Management Training 2019
- IVDR MDD CE Training 2021
- Minitab Basics 2023
Timeline
Quality Assurance Manager
Epredia
09.2017 - 09.2023
Quality Assurance Engineer, • Lead Auditor
Thermo Fisher Scientific
01.2011 - 08.2017
Quality Assurance Engineer
Dionex Corporation
03.2010 - 01.2011
Quality Assurance Supervisor
Dionex Corporation
01.2007 - 03.2010
Quality Control Technician II
ESA Biosciences
05.2001 - 12.2006
Bachelor of Science - Environmental Conservation/Affairs, Community Development
University of New Hampshire
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