Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant for QA Consulting Inc., specializes in project management for quality management systems processes, as well as overseeing daily operations and internal resources. Since joining the QA Consulting team in 2009, she has assisted clients with pre- and post-market activities; ensuring clients’ needs are met. Amber consults on quality system implementation, design controls, verification/validation, risk management, purchasing controls, and supplier audits. She also specializes in change control, device inspections, corrective and preventive actions, complaints, medical device reports, FDA and Notified Body audits, and regulatory remediation.
Prior to QA Consulting, Amber worked with life sciences and investment executives across the U.S. to facilitate in-depth consulting work in the healthcare space with the Gerson Lehrman Group in Austin, TX. Her work concentrated on medical devices, pharmaceutical/biotech, clinical research, technology, managed care, and hospital administration. Amber has also worked at Reliagene Technologies, a DNA sample processing laboratory in New Orleans, LA, where she gained knowledge and appreciation for quality assurance and quality control safety standards.
Amber has a B.S.E. in Biomedical Engineering from Tulane University in New Orleans, and an M.S.E. in Engineering Management from the University of Texas at Austin. Amber holds certifications as an ASQ Certified Quality Auditor (CQA) and an ASQ Certified Quality Technician (CQT).