QA Consulting, Inc.
Amber Hilfiger is an experienced professional in the field of medical device quality assurance. Currently serving as a Quality Manager at Watkins-Conti Products, Inc. since September 2023, Amber also operates as an Independent Consultant, providing expertise in medical device quality assurance since May 2020. Amber has held multiple roles at QA Consulting, Inc. since November 2009, including Principal Quality Engineering Consultant and various management positions. Prior experience includes a managerial role at Gerson Lehrman Group and an associate scientist position at ReliaGene Technologies. Educational qualifications include a Master of Science in Engineering Management from The University of Texas at Austin and a Bachelor of Science in Biomedical Engineering from Tulane University.
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QA Consulting, Inc.
QA Consulting, Inc. is your trusted thought partner for innovative medical device consulting and outsourced quality assurance services tailored to meet your objectives throughout the product lifecycle. We offer custom solutions in the areas of: - Quality Systems - Regulatory Affairs - Microbiology Analysis From startups to multinational corporations, discerning medical device manufacturers of all sizes rely on our real-world knowledge, expert documentation, and mastery of industry protocols and procedures to navigate today’s constantly evolving regulatory environment. We are quality connoisseurs that help you jump through compliance hurdles with ease. Our areas of expertise include: - Quality system development - Audits (internal, supplier, notified body) - U.S. FDA strategy - Post-market compliance - Microbiology (biocompatibility, bioburden, endotoxin, sterility, and more) - Helping startups bring their first product to market Lean into quality with medical device systems everyone can trust.