Our Consultants
Anne Wilson
Anne Wilson founded QA Consulting, Inc. in December 2000. She has 20 years of Technical Management, Quality Assurance Engineering and Regulatory experience in the Medical Device Industry. Her focus is on quality system development, regulatory affairs and validation. Anne’s problem solving skills and business acumen have enabled her to establish new quality processes, determine and articulate the impact of quality issues and implement value added solutions.
Anne has a broad base of experience ranging from development of Design Assurance systems in the R&D environment through the optimization and maintenance of manufacturing Quality Systems. She has been involved in FDA and CE certification audits for several device manufacturers. Anne has a B.S. in Biomedical Engineering from Vanderbilt University and a MBA from the University of Colorado. She holds ASQ Certifications as a Quality Manager, Quality Engineer and Quality Auditor. She is also RABQSA Certified Principal QMS Auditor and SQA Registered Quality Assurance Professional in Good Laboratory Practice.
Sallie McLaughlin
Sallie McLaughlin joined forces with QA Consulting, Inc. as a specialist in sterilization and microbiology. She has 13 years experience at the Food and Drug Administration and 24 years in the medical device industry. She has implemented microbiology test laboratories for two medical device companies and her sterilization experience encompasses virtually all industry recognized practices. Sallie is a frequent speaker at industry seminars in the areas of cleanrooms, isolators, sterilization and biocompatibility.
After working for FDA, Sallie joined Pfizer Hospital Products Group Schneider USA where she implemented a microbiological services department, managed sterility assurance activities, and a biocompatibility testing program for new products. At CarboMedics, 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.
R. Samuel Holland
R. Samuel Holland, Ph.D., R. Ph. has many years of experience at the executive level within the insurance sector, including Vice President for Quality Improvement at Accident Fund Insurance Company of America in Lansing, Michigan.
Educationally, Dr. Holland is a permanent Wharton Fellow of the Wharton School at the University of Pennsylvania and holds a Ph.D. in Applied Management and Decision Sciences, a Master of Science in Management, and a Bachelor of Science in Pharmacy.
Additionally, Dr. Holland holds several certifications in industry specific areas including : Recognition as a Certified Workers’ Compensation Professional (CWCP) from Michigan State University, Total Quality Management Certification from Indiana Wesleyan University, and a Health Insurance Associate (HIA) designation from the Health Insurance Association of America. He is also a senior member of the American Society for Quality, Senior Examiner for the Michigan Quality Council, and a licensed pharmacist.
Dr. Holland’s clients include many of the top 25 Workers’ Compensation carriers as well as large U.S. based Property and Casualty (P & C) Insurance companies.
Debby Powers
Debby Powers, MSN, joined QA Consulting Inc., in 2010 as a clinical research specialist. Debby has Bachelor of Science and Master of Science degrees in Nursing from the University of Texas at Austin and has 13 years of experience in clinical research with combined expertise in pharmaceutical and medical device clinical trials.
Prior to becoming a consultant, Debby was the Global Clinical Project Director at CarboMedics and has experience with PMA, 510 K approval with Class II and III cardiac medical devices. She has recently written and received pre-trial approval for a cardiac medical device protocol submitted to the Competent Authorities in the European Union.
Amber Combs
Amber Combs joined QA Consulting as a Quality Engineering Consultant. She specializes in quality management systems processes including quality system implementation, design controls, verification and validation, risk management, and supplier audits. Amber has worked with medical device clients focused on spine, orthopaedics, women’s health, infant health, and home health. She has worked closely with these clients to establish and maintain compliance with 21 CFR Part 820, ISO 9001:2008, ISO 13485; ISO 17025, and 21 CFR Part 11. Amber’s experience includes project management of product design through market release and documentation of design history files; design, process, and software verification/validation protocols and reports; and corrective and preventive action (CAPA) systems. Amber has a B.S.E. in Biomedical Engineering from Tulane University, a Master’s in Engineering Management from the University of Texas at Austin, and is an ASQ Certified Quality Auditor.
Angela Winegar
Angela has over ten years of experience working in the medical device, pharmaceutical, and biotechnology industries. Prior to her role at QA Consulting, Angela served as a manager in Accenture’s Health and Life Sciences division where she worked with clients such as Boston Scientific, Wyeth Pharmaceuticals, Hoffman La Roche, and Abbott Laboratories. She specializes in training and documentation of quality management systems and also performs the data analysis and documentation for design and process validation protocols and reports. Angela’s work at QA Consulting has expanded to include sterility assurance and design history file compilation and maintenance. Angela has a BA degree in Molecular Biology from Princeton University and a MS degree in pharmacy administration from the University of Texas at Austin.
Jill Gazlay
Jill Gazlay teamed with QA Consulting after working for several years as a Quality Assurance Engineer for CarboMedics, a Class III Medical Device Manufacturer. Since joining the QA Consulting team, her breadth of experience has expanded through consulting for a range of medical device manufacturers, including Abbott Spine, Encore Orthopedics, Luminex, and LDR Spine. Jill has a BS in Biomedical Engineering from Texas A&M University.