The Know-How to Know How
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Fergal McAndrew – Partner and Principal
Fergal has over 15 years in the medical device field and is a certified six sigma black belt and project manager. His extensive quality system and operational excellence knowledge allows him to implement compliant lean quality systems without negative impact on operational performance.
David Campo - Partner and Principal
David has over 10 years of experience in quality systems, regulations, and manufacturing operations of the medical device industry. His extensive experience allowed him to successfully lead projects-related implementation/improvement of countlessquality systems and cGMP. Starting with quality engineering, David has worked in all the major functional areas of the industry (Quality Engineering, Manufacturing operations, Engineering operations, Regulatory/Compliance, R&D, & Management), making him not only a well-rounded engineer, but also a manager that knows the importance of each functional area and how these disparate areas must interact with each other to achieve operational excellence.
Carolyn Schaefer – Principal (Quality Systems)
Carolyn is an accomplished, results-driven quality professional with over 25 years of experience in the highly regulated medical device industry.
Carolyn has significant experience representing top industry leaders in FDA interactions, including effective management of FDA inspections, management of FDA 483 responses and Warning Letter activities. She is also skilled in establishing simple and effective quality systems that pass FDA inspections, demonstrating measurable outcomes, and improving site and corporate quality systems including effective utilization of CAPA.
Ernesto Cruz – Senior (QS Implementation)
Ernesto uses his extensive knowledge in all aspects of QS requirements. He is adept at identifying gaps between current state and federal regulations and driving required change. Ernesto’s ability to interact easily with all levels of an organization allows him to effect change with minimum disruption to ongoing operations.
Chris Bouche - Senior (Lean Implementation and Operational Controls)
Chris has transformed both the quality and operational performance of many organizations through lean implementation. His ability to read a plant and identify waste is second to none and allows for quick planning and cost-savings implementation. His in-depth knowledge of all aspects of equipment qualifications and process validation is crucial as it enables him to ensure that all changes are done in a compliant manner and to identify validation gaps that require remediation as part of project scope.
Earl Davis – Senior (Risk Management)
Whatever the size or structure of your company, Earl can tailor a compliant risk management strategy to fit. Earl’s grasp of risk management requirements, tools and methodologies allows him to easily work within any company’s risk management system and enhance its ease of use and compliance to regulations. Whatever your risk management requirements may be, Earl will deliver.
David Andrade – Senior (Process Development and Operational Controls)
If you have the product, David can build it! Utilizing his mechanical, six sigma black belt and analytical expertise, David can quickly develop concepts, trial prototypes and determine optimal processes and process windows to deliver consistent products. Furthermore, his ability to quickly grasp product specs allows him to work with R&D teams to develop and validate test methods, aiding in reducing typical critical path activities.
Jefferson Isles - Junior (QS Implementation)
Even though Jeff has only a few years of experience working in the medical device industry, his master’s degree in biomedical engineering has enabled him to develop an analytical mind aimed at bridging the gaps between manufacturing operations and written procedures. He has a very practical approach to practice versus procedure problems, ensuring that the voices of the operators are being heard and translated to comprehensive manufacturing procedures.
Dan has over 30 years of experience in quality systems and FDA and EU regulations. He has developed and implemented entire quality systems for small and mid-level medical device companies. His extensive experience in these fields makes him the perfect auditor and remediation engineer. He has successfully led countless FDA and/or any other regulatory body audits and has successfully remediated any findings. Lastly, he also has extensive experience in design assurance and validations.
Charlie has over 30 years of experience in the manufacturing operations and mechanical engineering fields of several industries. His vast experience with equipment of all kinds allows him to design, validate and implement flawless manufacturing production lines. His “back-to-basics,” quality-driven approach to any problem has enabled him to develop a reputation as the guy that you need to have when a production line needs to be improved or transferred to a new location.