Amber Hilfiger

Experience

1. Principal Quality Engineering Consultant

   Qa Consulting, Inc

   Nov 2009 — Present

   Principal Quality Engineering Consultant May 2020 - PresentDirector of Operations & Senior Quality Engineering Consultant Nov 2016 – Apr 2020Operations Manager & Senior Quality Engineering Consultant Jan 2016 – Oct 2016Operations Manager & Quality Engineering Consultant Jan 2012 - Dec 2015Quality Engineering Consultant Nov 2009 – Dec 2011At QA Consulting, our goal is to provide medical device manufacturers with exceptional consulting services that fulfill our clients’ internal goals while complying with regulations, and industry practice.The medical device landscape is fast-paced and constantly evolving. It is our job to maintain cutting-edge knowledge of current and impending FDA regulations and industry trends so that we can keep our clients savvy of this unique industry. We apply a team-based approach to your quality, regulatory, and microbiology needs to ensure that you obtain the maximum benefit of our panel of experienced, nationally recognized consultants. Whether you need expert consultant advice or to completely outsource your quality and/or regulatory department, QA Consulting will tailor a plan to accommodate your strategic goals.Amber joined the QA Consulting team in 2009. As a Quality Engineering Consultant she specializes in project management for quality management systems processes including pre-market activities such as quality system implementation, design controls, verification/validation, risk management, purchasing controls, and supplier audits. Amber also conducts and advises on post-market activities including change control, device inspections, corrective and preventive actions, complaints, medical device reports, and FDA and Notified Body audits. As Operations Manager, her role includes managing internal resources and overseeing day-to-day operations to best meet client needs.

Education

• Tulane University

  BSE, Biomedical Engineering

  2001 — 2005

• The University of Texas at Austin

  MSE, Engineering Management

  2007 — 2009