ABOUT

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.

Anne Holland

Anne Holland

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.

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Amber Hilfiger

Amber Hilfiger

Director of Operations and Principal Quality Engineering Consultant

Amber Hilfiger, Director of Operations and Principal 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).

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Mallori Groh

Mallori Groh

Business Manager

Mallori joined the QA Consulting team in 2010. She has 16 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.

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Laura Lakemeyer

Laura Lakemeyer

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).

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Silas Minnick

Silas Minnick

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.

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Sallie McLaughlin

Sallie McLaughlin

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.

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Diane Sudduth

Senior Regulatory Consultant

Diane Sudduth, Senior Regulatory Consultant, is a prior FDA reviewer with over 20 years of experience in the pharmaceutical and medical device industries. Diane focuses on regulatory submissions, clinical research protocols, clinical evaluation reports, and technical documentation. Diane has experience with Class I, II and III medical devices in US and Class IIa, IIb and III in the EU. Diane exhibits depth of knowledge in submission of 510(k), 513(g), IDE, Original PMA and PMA Supplements in a multitude of technologies. She has notable skills in technical and regulatory writing and research in pharmacovigilance, medical monitoring/safety/vigilance.

She has significant experience in specialty areas including combination products, cardiovascular stents, wound care, respiratory and ENT devices, orthopedic implants, 3D printing, defibrillators, radiologic devices including ultrasound, CT Scan, Proton Therapy and other software only or software contained medical devices.

While in industry, Diane was a Quality Systems Associate Director for a large medical device company, with specific experience in design, installation, and continuous improvement of 21 CFR Part 820 and ISO 13485 compliant quality systems as well as dealing with FDA and third party inspections, Consent Decree, and Warning Letter responses. Other experiences include device design, manufacturing engineering and validation. 

Diane holds a B.S in Chemistry from State University of New York, a M.S. in Biology from Loyola University of Chicago, a Master of Applied Statistics from Louisiana State University, and a Doctorate in Veterinary Medicine from Louisiana State University.

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Babacar Diouf

Babacar Diouf

Senior Quality Engineering Consultant

Babacar Diouf, Senior Quality Engineering Consultant, joined QA Consulting Inc. in 2019. Babacar has over 24 years of Engineering, Quality Engineering, Regulatory Affairs, and Quality Management Systems, including 10 years as an executive in regulatory affairs and quality systems. Babacar has experience in the entire lifecycle of medical devices from concept to post-market activities. Babacar has obtained market clearance in the USA, Canada, EU, South Korea, ASEAN, Brazil, and Australia with successful regulatory submissions (Presubmission, IDE, 510(k), EU Technical Files, and Design Dossiers). Babacar specializes in quality management systems in a manufacturing environment. He has extensive experience in product and process development with an emphasis in regulatory planning, design control activities, risk management, clinical evaluation, biocompatibility, sterilization validation, process validation, packaging validation, labeling, facility validation, and cleanroom validation.

Babacar previously worked in the mining industry in Africa at Ashanti Goldfields Ltd in geochemical exploration for gold and base metals, at Autoliv ASP (automotive safety products), at CRI Medical Devices (Biomerics), and 3DT Holding, LLC.

A native of Senegal, Babacar speaks four languages and holds a Geological Engineering degree from the Institute of Earth Sciences – Cheikh Anta Diop University of Dakar, Senegal, and a master’s degree in Executive Leadership and Organizational Change from Northern Kentucky University.”

Babacar is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professionals Society (RAPS). Babacar is an ASQ Certified Quality Auditor, certified ISO13485:2016 Auditor, a certified MDSAP model auditor, and an ASQ Certified Quality Engineer.

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Jill Gazlay

Senior Quality Engineering Consultant

Jill Gazlay, Senior Quality Engineering Consultant, joined the QA Consulting team in 2003. Jill has consulted for a wide range of medical device manufacturers in her 20 years of medical device industry experience primarily in quality engineering and sterility assurance.  Jill’s strength is combining her engineering technical capability with her quality system and standards knowledge to devise and implement solutions for QA Consulting Clients. Jill has consulted on product, packaging, and software validations, risk analyses and quality systems.  Most recently, Jill has gained extensive experience in ethylene oxide sterilization validation, comparative resistance studies and EO residuals, including compliance to pediatric residuals limits.

Prior to joining the QA Consulting team, Jill worked for Sulzer Carbomedics as a Quality Engineer overseeing final assembly and packaging operations for Class III medical devices.  Jill holds a BS in Biomedical Engineering from Texas A&M University.

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Jennifer Vondran

Jennifer Vondran

Quality and Regulatory Consultant

Jennifer Vondran joined the QA Consulting, Inc. team in 2021 as a Quality and Regulatory Consultant. In MedTech, Jennifer has worked on cardiac pumps, drug eluting stents, hemostatic and laparoscopic patches, neonatal monitors, embolic protectors, orthomusculoskeletal health monitors and other cardiovascular and endovascular device projects in various Technology Management positions. Jennifer’s experience ranges from R&D, Manufacturing Operations, Technology Transfer, Quality and Regulatory capacities. Jennifer is very familiar with ISO 13485 QMS certification, QMS operations and maintenance, and US regulatory pathways and applications. She is co-author of the textbook Engineering Innovation: From Idea to Market Through Concepts and Case Studies, a resource that is being utilized by the bioengineering/biomedical departments at various universities, including Texas A&M. Jennifer’s clients (that range from start-ups to emerging/mid-size to multi-tier/global) value the tools and techniques she employs to solve problems and ensure successful outcomes. With a BSE in Biomedical Engineering and a MSE in Material Science and Engineering from Drexel University, Jennifer also holds a Project Management Professional certification and has excelled as a versatile technology and management consultant for the life sciences and healthcare sector since 2007.

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Jerry Sudduth

Jerry Sudduth

Quality and Regulatory Consultant

Jerry Sudduth, Quality and Regulatory Consultant, joined QA Consulting Inc. in 2021. Jerry has over 20 years of experience in the Medical Device field as well as seven years of Quality Management knowledge in Aerospace. Jerry has held positions as a Manufacturing Specialist, Quality Assurance Specialist, Quality Manager, and Vice President of Quality. Jerry graduated from Florida Atlantic University with a Master’s in Applied Mathematics – Biostatistics.

In the regulatory arena, Jerry’s expertise includes FDA Premarket Notifications, FDA registration and listing, and Clinical Evaluation Reports. Jerry also has compliance experience interacting with regulatory agencies such as the FDA, EU Notified Bodies and Health Canada. Additional proficiencies include generation and implementation of Quality Management System (QMS) documents (ISO 13485, AS9100, AS9120, PPAPs), clinical protocols, statistical analysis, and EU transition documentation.

In quality, Jerry’s strengths include design verification, process validation, cleanroom qualifications, post-market corrective/preventive actions, and labeling. 

Jerry held positions at notable companies including Bristol Myer Squib, Linvatec, and Conmed Corporation. He holds certification as an ASQ Certified Quality Inspector (CQI) and ISO 13485 Auditor from Exemplar Global.

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Kristen McClellan

Kristen McClellan

Quality Associate

Kristen McClellan, Quality Associate, joined QA Consulting in 2021. Kristen supports clients to implement Quality Management Systems, design controls, risk management, design verification, generation of validation protocols and reports, and post-market activities.

Kristen joins us with prior experience in medical device manufacturing and biologics, quality management systems and the field of legal research. She holds a B.S. in Biology and Environmental Science from West Texas A&M University.

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Samuel Holland

Samuel Holland, Ph.D., R.Ph.

Principal Consultant

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.

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Nathan Glass

Nathan Glass

Senior Quality Engineering Consultant

Nathan Glass, Senior Quality Engineering Consultant, joined the QA Consulting team in 2021. Nathan has a wide range of experience in his 20 years’ of work in life sciences. He has worked primarily in medical device product development and manufacturing engineering. He also has experience in clinical pharmacy compounding, quality system implementation, design controls, risk management, project management, device, process and equipment validations, and engineering leadership. Nathan has consulted on audits (ISO 13485:2016, FDA QSRs, MDSAP), UDI implementation, sterilization validations, risk management, and design for manufacturability.

Nathan has extensive experience in project management being responsible for budgets and timelines for development projects, manufacturing transfers, QMS implementation, and other company initiatives. His manufacturing experience includes injection molding, extrusion, plastics welding, machining, packaging sealing systems, thermoforming, and others. He has managed process development projects including equipment acquisition, work cell setups, process qualifications (IQ/OQ/PQ), and quality assurance processes. He has developed novel applications of additive manufacturing (3D printing) for prototyping, tooling, fixturing, and component development.

Nathan has worked with clients to develop designs in the areas of anesthesia and respiratory care, orthopaedics, coronary and peripheral arterial devices, obstetrics, gynecology, implantable, neurological devices, ENT, hospital beds and mattresses, surgical kits, biopharma and other fluid containment systems, sterile packaging, COVID-19 therapies, and others for various markets including US (FDA), Health Canada, and the European Union (CE mark).

Prior to joining the QA Consulting team, Nathan worked as a Product Development Engineer, Engineering Manager, and VP of Engineering and Quality overseeing all quality and engineering activities for a US-based medical device contract manufacturer. Nathan holds a BS in Biomedical Engineering from Purdue University.

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