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
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.
Ella Wheeler
Director of Operations and Senior Quality Engineering Consultant
Ella Wheeler specializes in project management for quality management systems processes, as well as overseeing daily operations and internal resources. Customer and patient safety focused, Ella consults on quality system implementation, from concept to lifecycle and post-market activities management, risk management, purchasing controls and supplier audits and qualifications, in alignment with ISO13485:2016 and ISO9001:2012 requirements. She also specializes in change control, continuous improvements through Lean and Six Sigma methodologies, root cause investigations, corrective and preventive actions, complaints, and medical device reports.
Ella has a B.S. in Chemical Engineering from “Gh Asachi’ Polytechnical Institute, Iasi, Romania, an M.S. in Macromolecular Chemistry from Louisiana State University (LSU) in Baton Rouge, LA and a M.S in Clinical Chemistry from Rochester Institute of Technology (RIT), Rochester, NY. Ella holds Six Sigma Green Belt certification, Project Management (PMI) certification, BSI ISO13485:2016 Lead Auditor certification and ISO9001 Lead Auditor Certification.
Amber Hilfiger
Principal Quality Engineering Consultant
Amber Hilfiger specializes in project management for quality management systems processes. 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).
Diane Keyser
Senior Quality Engineering Consultant
Diane Keyser has over 30 years’ experience in minimally-invasive medical disposable and reusable device development. Diane’s broad experience encompasses early-stage concept design through high volume manufacturing with both start-up and Fortune 500 companies. In executive management, Diane was responsible for developing and maintaining the QMS, including qualifying, validating and managing an EQMS (Grand Avenue Software – GAS). She has hands-on experience managing and overseeing all aspects of compliance with QMS, including management reviews, training, CAPAs, supplier audits/approvals, equipment management, NCRs, external documents, document control and incoming / in-process / final inspection. As a design, manufacturing, and quality engineer, Diane has worked effectively within a wide range of Quality Management System (QMS) frameworks and was directly responsible for documentation of design control and risk management activities, such as FMEAs, input/output matrices, and verification / validation test protocols and reports.
Prior to joining the QA Consulting team, Diane was Director of Quality at Eximis Surgical (a start-up), Program Manager at Nordson Medical (a contract developer/manufacturer), Project Leader at Covidien/Medtronic, VP Engineering at Encision (small device developer/manufacturer) and multiple roles within Guidant/Boston Scientific. Diane holds a MS in Mechanical Engineering from Stanford University and BS in Mechanical Engineering from MIT. She is a certified ISO 13485:2016 Lead Auditor.
Silas Minnick
Senior Quality Engineering Consultant
Silas Minnick 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.
Sallie McLaughlin
Principal Microbiology Consultant
Sallie McLaughlin 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.
Lindsay Fitzgerald
Senior Microbiology Consultant
Lindsay joins QA Consulting with over 14 years in the Quality Medical Device industry. Her experience is comprised of Quality Management System development and maintenance as well as Microbiology and Sterilization services.
In the QMS realm, Lindsay specializes in Non-conformance and RC/CAPA lifecycle management, Change Management, Internal Audit, Document & Records control, Post-Market Surveillance activities such as customer feedback and complaint trending, and development of Management Reviews & Product Quality Reviews for on-going analysis of QMS and product performance. Lindsay holds an Internal Auditor certification to ISO 13485:2016.
In Microbiology & Sterilization, Lindsay has experience in developing and overseeing a microbiology & environmental monitoring program for controlled environments and cleanroom management, including knowledge and involvement in biofilm remediation and prevention. She also has hands-on experience with the sterilization of medical devices through cycle design, development, validation, and on-going control.
Prior to joining QA Consulting, Lindsay held positions as Quality Systems Manager and Quality Microbiology & Sterilization Services Supervisor for major medical device manufacturer Bausch & Lomb. She holds a bachelor’s degree in Biological Sciences from the University at Buffalo, as well as a Master of Science degree in Biology Education from Nazareth College of Rochester.
Diane Sudduth
Senior Regulatory Consultant
Diane Sudduth 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.
Elaine Daniell
Senior Microbiology Consultant
Elaine M. Daniell brings 35 years of experience in the areas of medical device and biologics sterilization, environmental microbiological control and laboratory testing associated with sterilization processes, manufacturing and product monitoring. Elaine has been consulting for nearly 5 years and has held industry leadership positions in large medical device manufacturers with responsibility for worldwide sterility assurance programs and sterilization process optimization.
Elaine is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) for over 20 years and actively participates in industry standards development as part the International Standards Organization (ISO). Elaine is the current co-chair of the WG2 Radiation for AAMI and an ISO US expert for WG2 Radiation Sterilization. Elaine holds certifications by ACI as Certified Sterilization Specialist in Ethylene Oxide and Radiation Sterilization and by ASQ as a Certified Quality Auditor. Elaine has a B.S. in Biology from Georgia State University.
Babacar Diouf
Senior Quality Engineering Consultant
Babacar Diouf 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.
Jill Gazlay
Senior Quality Engineering Consultant
Jill Gazlay 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.
Nathan Glass
Senior Quality Engineering Consultant
Nathan Glass 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.
Kathryn Johnson
Senior Usability Engineering Consultant
Kathy Johnson has more than years experience in both the medical device and in vitro diagnostics industries. Kathy started out her career in technical training, developing and delivering technical training programs and procedures. Delivering training gave her unique insights into the user’s frustrations, needs, and wants during training sessions. Kathy brings new skills to the team in Human Factors/Usability Engineering. She spent six years in the medical device and IVD training field. She was responsible for launching an HFE/UE program and team. She now shares her expertise with medical device and IVD companies helping them comply with HFE/UE standards and guidance and make safe and effective products for use.
Kathy has a B.S. in Biology from Boston College and an M.S.E. in Biomedical Engineering from the University of Texas at Austin.
Jerry Sudduth
Quality and Regulatory Consultant
Jerry Sudduth 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.
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.
