QSCS’s strength comes from our core stable of highly qualified and experienced professionals who time after time exceed the expectations of our clients.
Our consultants have experience and skills representing a who’s who within the Medical Device and Pharmaceutical Industry. They are industry leaders coming from all different levels (Vice Presidents, Directors, Managers, and Engineers) and from all different functions (Quality Assurance, Regulatory Affairs, Research and Development, and Operations). They have worked in small start-up enterprises up to multi-billion dollar, multinational corporations.
If you are looking for quality/regulatory support or if you are looking for data analysis support or the implementation of Continuous Improvement opportunities, QSCS can help.
Please see brief descriptions of our team capabilities below.
Quality System/OPEX SME
--- is an accomplished quality executive with twenty-five years of domestic and international experience. During his career --- has built a solid foundation in quality, engineering and manufacturing through progressive positions focused on Quality Systems, Design Assurance, and Operational Excellence with multiple fortune 100 companies.
--- is also a Master Black Belt has created, launched, and lead a program throughout a $10B organization, leading to over $250MM in savings within 3 years. Areas of focus spanned Operations, R&D, and Transactional processes.
---has more than 20 years of direct experience in medical device regulatory compliance within the engineering, manufacturing, servicing, supplier, quality, complaint, recall, and audit management fields. --- is an experienced facilitator of FDA inspections, has contributed to the development of responses at all levels of regulatory enforcement actions, and has participated in numerous FDA/Corporate meetings, directly and as a consultant. --- has served as a lead auditor for internal audits, external audits, and mock FDA audits.
Design Control SME
--- is a former Senior Research and Development Executive with over 25 years of experience working for Fortune 500 Companies in the Medical Device Industry. --- has managed interdisciplinary groups that have successfully designed and commercialized medical disposables and capital equipment resulting in the commercialization of over 60 new products. --- has extensive knowledge in Design Controls including DHF creation and management, Verification and Validation activities (both Product and Process), Hazards Risk Analysis, Product Change Control, Design Transfer, and Post Market Surveillance.
Process and Production Controls SME
---has over thirty years of experience in regulatory affairs, quality assurance, engineering, and management. ---has extensive expertise in medical device design assurance, verification, validation, and device submissions. He has validated pharmaceutical manufacturing processes, medical device manufacturing processes, laboratory processes and has extensive expertise in software validation. ---has traveled nationally and internationally to perform quality systems audits and inspections. He is knowledgeable in IEC 60601, IEC 62304, ISO 9001, ISO 14971, and ISO 13485. He has developed and submitted 510(k) submissions for various Class II. For the last 4 years, --- has spent the majority of his time working with Medical Device firms to correct 483, Warning Letter, and Consent Decree deficiencies.
Risk Management SME
Specialist in implementing risk management within quality management system processes, linking post-market surveillance and vigilance/MDR reporting/Health Hazard Evaluations to product risk assessment. Unique combination of clinical, quality, regulatory and technical expertise. Over 40 years’ experience in medical device, diagnostics, and clinical laboratory industries, including leadership positions in quality, regulatory, clinical evaluation, R&D, and post-market support. …worked with firms in Belgium, Finland, France, Germany, Ireland, Italy, Japan, Sweden, Mexico, Netherlands, Puerto Rico, UK, and the USA. Served as a third-party expert to firms under Consent Decree, Warning Letter, Special Conditions of Probation, Import Detention, and Department of Justice investigation, as well as proactive firms improving their quality management/risk management systems, preparing for inspections, and ensuring regulatory compliance.
General QS Validation/OPEX Support
---has worked in the medical device industry for several years with a focus on manufacturing process validation and control. This specifically includes the drafting and execution of installation, operational, and performance qualifications in addition to test method validations. Authored and revised manufacturing work instructions, standard operating procedures, and test protocols. Has led teams for measurement system analysis and risk assessment initiatives. Familiar with regulatory requirements including ISO 13485 and 21 CFR 820. ---- holds a Bachelor's Degree in Biochemistry is a certified Six Sigma Green belt as well as an Eagle Scout.
Design Transfer SME
--- has over 25 years of engineering, quality systems, and design & development experience in Class I/II/III Medical Devices, combination products, and Pharmaceuticals. --- has been professionally consulting with Medical Device and Pharmaceutical firms for 10 years in remediation, corrective actions, and improvements to comply with global regulatory standards. Most of his clients have been cited for actions by FDA including consent decrees, or by other agencies for mission-critical quality system compliance deficiencies. His experience in the application, development, and implementation of numerous quality systems to meet global standards make him an excellent quality system investigator, process analyst, procedure(s) author, and trainer/implementer. …Specialty areas of subject matter expertise include Product Realization processes, Design Controls, Production, and Process Controls, Purchasing and Materials controls, Risk Management Processes, and Post-market surveillance and Design Change processes.
General QS Validation/CAPA Support
--- has over 5 years of experience in the medical device industry. Her time as a Quality Engineer with several diverse medical device manufacturers (large and small) has given her a broad understanding of a quality system. She has previously planned, prepared, and executed process validation protocols while developing strong technical writing skills. Her experiences in root cause analysis and non-conformance reporting have allowed her to make an immediate contribution to CAPA work-streams. --- holds a Bachelor of Science degree in Biomedical Engineering from the University of Miami.