Meet the Medical Device Experts
When you partner with us, you have access to a wealth of knowledge and experience. The industry’s best and brightest are available for counsel and advice.
CEO and Founder
Anne Holland combines more than 25 years of biomedical engineering with business acumen as founder and CEO of QA Consulting, Inc. Under her guidance, QA Consulting has grown from a local Austin-based firm, founded in 2000, to one of the leading HUB and WBENC-certified medical device consulting firms with clients throughout the nation. She is an expert in every phase of quality assurance from design concept and R&D through manufacturing/ production, and post-market surveillance for Class I, II, and III medical devices.
Anne’s expertise has been sought by medical device manufacturers, from startups to Fortune 500, to develop and implement compliant solutions that meet their quality and regulatory needs. She has been called as an expert witness on medical devices and regulatory compliance. Anne has conducted over 100 supply chain and internal audits. Clients rely on her thorough knowledge of good manufacturing practices (GMP), good laboratory practices (GLP), and regulatory remediation. She facilitates and responds to FDA and ISO 13485 Notified Body audits for manufacturers.
Anne gained much of her knowledge of quality assurance and manufacturing operations during 15 years of working in the field. Prior to beginning her consulting business, she worked for Sulzer Carbomedics in Austin, TX; Ohmeda Monitoring in Louisville, CO; Cobe BCT, Inc., in Lakewood, CO; Fischer Imaging in Broomfield, CO; and LA BAC Medical Systems in Englewood, CO. She holds a B.S. in Biomedical Engineering from Vanderbilt University in Nashville, TN, and an MBA from the University of Colorado in Denver, CO.
Anne holds certifications as an ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), Certified Manager of Quality / Organizational Excellence (CMQ/OE), Exemplar Global Quality Management System Lead Auditor, and Society of Quality Assurance Registered Quality Assurance Professional in Good Laboratory Practice.
Director of Operations and Senior Quality Engineering Consultant
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).
Mallori joined the QA Consulting team in 2010. She has 11 years of experience managing businesses in the healthcare industry and has a B.S. in Business Management.
Mallori is responsible for all human resources, accounts payable and accounts receivable, customer service, project setup, client budget management, marketing, legal and compliance, and IT operations of QA Consulting, Inc.
Senior Microbiology and Quality Consultant
Laura Lakemeyer, Senior Microbiology and Quality Consultant, joined QA Consulting in 2015. Laura advises on microbiological processes, biocompatibility analysis, auditing, quality systems, and post-market activities. Laura has more than 12 years of experience in both the medical device and pharmaceutical industries.
Prior to joining QA Consulting, Laura was a microbiologist at Coopers Pitman-Moore and KV Pharmaceuticals, a molecular biologist for Monsanto, and a Quality Assurance Manager for Forest Pharmaceuticals, Inc. and Ascension Orthopedics, Inc. Through these roles she gained knowledge of quality assurance and an appreciation for its critical role for manufacturers and became well-versed in regulatory standards. Laura has significant experience interacting with the FDA, DEA, OSHA and Notified Bodies as the lead for site audits.
Laura holds a B.S. in Microbiology from the University of Kansas and is an ASQ Certified Quality Auditor (CQA).
Senior Quality Engineering Consultant
Silas Minnick, Senior Quality Engineering Consultant for QA Consulting Inc., specializes in project management, quality system development, in vitro diagnostics and quality system remediation efforts. Silas joined QA Consulting in 2020 with extensive experience in Class II and III medical device manufacturing in every aspect of quality including process validations, inspection, metrology, supplier quality, audits, CAPAs and design control.
Before QA Consulting, Silas worked for numerous medical device companies over a 25-year span, including Johnson & Johnson Ethicon Endo Surgery, Sulzer Carbomedics, Zimmer Biomet, Luminex Corporation and On-X Life Technologies. He holds a B.S. in Mechanical Engineering from The Ohio State University.
In the late 1990’s to the early 2000’s Silas taught classes in manufacturing statistics at the Austin Community College (ACC) and local companies in the central Texas area. He also assisted in the development of certificate and associate degree programs in Quality Assurance. Silas served as an examiner for the University of Texas Center for Performance Excellence (UTCPE) to review applications and inspect organizations in the central Texas area applying for a local Malcolm Baldrige Quality Award and later served as a judge to evaluate and edit reports submitted by examiners.
Silas holds certifications from the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE) and Certified Manager of Quality / Organizational Excellence (CMQ/OE). In 2010 Silas was named as a Fellow from ASQ for his achievements and contributions to the advancement of quality.
Cinthia Gaona joined QA Consulting as a Quality Associate in 2019. Cinthia specializes in quality system generation and implementation, root cause analysis, corrective and preventive actions, complaints, medical device reports, technical writing, audits, gap analyses, change control, data analysis, continuous improvements, training and project management.
Prior to joining QA Consulting, Cinthia worked as a Post Market Quality Engineer for a privately-held medical device company, Inova Labs. In this role, she focused on reducing aging product complaints, improving timeliness of complaint closures, increasing company on-time training, performing data analysis and conducting trending. She also worked as a Quality Engineer for a world leader biotechnology company, Thermo Fisher Scientific. There, her experience included managing customer inquiries, handling post-market activities, resolving product quality concerns and addressing process gaps.
Cinthia has a B.A in Chemistry from The University of Texas at Austin and holds ASQ Certified Quality Auditor (CQA) and PMI Certified Associate in Project Management (CAPM) certifications.
Senior Microbiology Consultant
Sallie McLaughlin joined the QA Consulting team in 2004. She serves as QA Consulting’s resident expert in microbiology and sterilization, with over 30 years of diverse experience in the medical device industry. Sallie’s sterilization experience encompasses virtually all industry-recognized practices and her in-depth knowledge of FDA and regulatory practices make her a valuable member of the QA Consulting team. Her specialties include validating sterilization processes, biocompatibility testing, cleanroom validation, and environmental monitoring programs.Sallie’s experience includes 13 years at the Food and Drug Administration (FDA) in Minneapolis, MN. In this role, she was responsible for microbiological analyses, team investigations, and method development/validation. Sallie also worked at Pfizer Hospital Products Group Schneider USA in Minneapolis, MN where she implemented a microbiological services department, managed sterility assurance activities, and a biocompatibility testing program for new products. Most recently, Sallie worked in Austin, TX at CarboMedics where she developed in-house expertise in Microbiology, directed all sterility assurance activities, implemented environmental monitoring programs, and was responsible for sterility assurance for a sister company.
Senior Regulatory Consultant
Sandie Roth joined QA Consulting in 2018. She advises on regulatory compliance, regulatory submissions and quality assurance. Over the course of the last 15 years, Sandie has managed many stages of the product life cycle including R&D, product development, device testing, quality, clinical, regulatory, marketing, and commercialization of orthopaedic devices predominantly in the areas of the spine and upper extremity. Her regulatory experience includes submissions through the US FDA 510(k) program, Technical Files and Clinical Evaluation Reports for the EU, and the Health Canada Special Access Program. Additionally, Sandie has managed OUS pre-market clinical studies that were designed to provide clinical evidence for US and EU approval. She has worked for large orthopaedic companies including Biomet and small start-up companies including Nexgen Spine and Wenzel Spine. Sandie holds an MSc in Medical Biophysics from Western University and a BASc in Mechanical Engineering from the University of British Columbia.
Samuel Holland, Ph.D., R.Ph.
With over 30 years of pharmacy, managed care and Workers’ Compensation insurance experience, Dr. R. Samuel Holland, Ph.D., R.Ph., has substantive experience with complex healthcare issues and the associated impact to injured workers. In his current role his responsibilities are directed at helping clients improve the management of their Workers’ Compensation medical and pharmacy spend by focusing on optimizing drug therapies and deploying pain management techniques.
Dr. Holland has many years of experience at the executive level within the insurance sector including Chief Clinical Officer for Summit Pharmacy Solutions in Brentwood, Tennessee and Vice President for Quality Improvement at Accident Fund Insurance Company of America in Lansing, Michigan.
He is also a permanent Wharton Fellow at the University of Pennsylvania, a, senior member of the American Society for Quality, Senior Examiner for the Michigan Quality Council and a licensed pharmacist.