Matt W.

Experience

• 

  Advantech

  Oct 2011 - May 2015

  Quality Engineer

  • Compile, analyze, and monitor customer dead-on-arrive and WIP failure trending reports• Support company ISO 9001/13485 compliance and function as document control rep.• Coordinate customer questionnaire and survey and support customer onsite audits

• 

  Foxconn

  May 2015 - Feb 2016

  Quality Engineer

  • Support New Product Introduction quality issues with customers and cross-functional teams• Streamline and monitor RMA rework process optimizing screening/sorting/rework schedule• Monitor spare part inventory to reduce turnaround time and excessive end-of-life expenses

• 

  Advantech

  Feb 2016 - Jul 2018

  Quality Assurance Supervisor

  • Maintain QMS compliance with ISO 9001 and ISO 13485 and lead transition to MDSAP• Supervise quality assurance functions including NCMR, ECO, and SOP review• Collaboratively complete customer questionnaire and survey regarding company operations• Review Master Service Agreement (MSA) on quality management system related terms

• 

  Medical Instrument Development Laboratories, Inc.

  Jul 2018 - Jun 2021

  Regulatory Affairs Specialist

  • Maintain distributor matrix of product approval status for APAC/EMEA/LATAM regions• Perform product release for gamma irradiation and ethylene oxide (EtO) sterilization• Support regulatory affairs activities including pre-market and post-market submissions• Handle customer complaints and perform data trending for management review

• 

  Abbott

  Jun 2021 - now

  • Partner with cross-functional teams to drive product development and launch• Lead submissions for pre-market new product and post-market sustaining projects• Provide regulatory advice for advertising and promotional materials to HCPs• Experience in life sustaining software contained medical devices acting BU and global RA

  • Senior Regulatory Affairs Specialist

    Nov 2024 - now

  • Regulatory Affairs Specialist II

    Jun 2021 - Nov 2024