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“Proven Experience”
Joe has a dynamic and results-oriented career with broad based management and consulting experience in all areas of Manufacturing Operations, Engineering, and Quality in the heavy industrial, discrete manufacturing and medical products manufacturing industries. Joe has held leadership positions in several Fortune 200 ($12B) companies and has been a partner in a major consulting firm.
In addition to his background in manufacturing operations, Joe has been Chief Engineer/Director of Engineering for two different competitor organizations in the Fluid Power industry. He has also led Quality Management System deployment in R&D facilities around the world.
Joe’s relevant experience includes as Champion of the Compliance Master Plan, responsible for the redesign of the device quality management system to assure a fully integrated system compliant to ISO13485 and 21CFR820. This $40+ million project was delivered on-time, under budget, withstood the test of FDA regulators and Notified Body auditors, and avoided an expected consent decree.
Joe has also remediated 14 consumable product families that had been developed without the protection of appropriate design controls. This included development and approval of design verification plans for all product families compliant to the EU Medical Device Directive and the new EU Medical Device Regulation (EU-MDD/MDR).
He helped lead and assure delivery of two new product platforms FDA Form 510(k) and remediated two platforms to acceptable design and regulatory status.
Additionally, Joe was Single Point of Accountability (SPA) for cybersecurity of medical devices for a $1.5 billion manufacturer. Provided testimony before Congress on the subject.
He led the selection and deployment of several major IT solutions in Part 11 compliant quality management systems. These included free-standing applications in Complaint Management, CAPA, and Risk Management (ISO 14971) as well as integrate Product Lifecycle Management systems.
He holds a Master of Science degree in Systems Engineering and a Bachelor of Science in Engineering Technology, both from Northern Illinois University. He is a retired licensed Professional Engineer.
Currently Joe is Immediate Past President, Northern Illinois University Alumni Association.
Ron has over 50 years of experience in the FDA regulated industries. For 25 years he worked as an investigator and supervisory investigator in the field organization of FDA, and at one time or another was responsible for carrying out FDA field investigation and inspection mandates in all industries regulated by the agency. His FDA career included numerous long term details in FDA Headquarters.
Ron’s consulting experience has been primarily in the medical device and pharmaceutical industries with major emphasis in medical devices. Consulting work has included GMP and QSR compliance, quality system and pre-approval audits and mock inspections, training in all aspects of regulatory compliance as well as FDA inspection prep and readiness training, quality system gap analyses, and consulting to provide regulatory advice and guide improvements with the goal of building compliant and sustainable quality systems. He frequently works with companies following adverse FDA inspections to assist in developing strategies for achieving compliance and has been engaged along with other consultants as a third party expert for companies under Federal Consent Decree.
In addition to assessing regulatory vulnerabilities through audits, he provides assistance in developing corrective and preventive action plans to remediate the vulnerabilities. He assists in writing responses to FDA-483s and Warning Letters, and he provides compliance and quality system implementation guidance and training as needed to address shortcomings. This includes development of compliance master plans and quality management metrics. He also performs corporate-wide benchmarking and best practices evaluations, with subsequent recommendations for improvements. He has assisted various clients by serving in interim positions such as a year-long tour as the Corporate Vice President of Quality for a major global medical device manufacturer.
Drew has over 35 years of experience composed of DoD, Nuclear Power and Medical Products. He has managed teams and coordinated work in Manufacturing, Quality and Research and Development. As a manufacturing manager he managed the assembly and test of electronics for the F15, C130, B1B, B2 and Space Shuttle aircraft. This experience gave Drew a solid understanding of Design Engineering, Quality and Manufacturing in a highly regulated environment.
In nuclear power generation he learned the operation of the plant including operator training which bolstered his knowledge and experience in control systems, systems engineering, service and quality of components. Developing his skills in auditing, Drew became a lead auditor for 23 nuclear power plants across the country building his skill in assessing quality systems, documentation and quality of execution.
Transitioning into Medical Products Drew supported development and supplier engineering ultimately co-developing a supplier control process and tool set that was used at multiple companies nationwide. In addition, he was the architect and driver for the development and implementation of an integrated electronic change control system connecting the DHF and DMR. This led to developing quality systems from scratch and managing development at 3rd party development partners.
Creating a Compliance Engineering function allowed Drew to resolve issues with NRTLs, streamline qualifying products to standards and setting the baseline expectations for designing to standards, testing to standards and tracing to standards. He as over 20 years of managing technical files for multiple regional regulatory registrations. As a part of this Drew was Co-Chair for 60601-2-24 and participated in the standards development in the TC 62 committees.
As the lead for engineering under a consent decree Drew developed a deep understanding of the FDA expectations and how to plan and execute both product and quality system improvement plans. With 20 years of front and back room audit experience Drew is well versed in structuring information for audit defense, process improvement and audit management.
Hector is a 30 year-plus experienced senior quality professional with extensive background in small and large volume sterile injectables and medical devices. He has cultivated significant strength and experience in addressing complex issues and working with multidisciplinary teams. Hector’s track record demonstrates passion for developing quality systems within pharmaceutical, medical device, and biotechnology companies that add value and efficiency in addition to being compliant with regulations. Additionally, he has extensive experience interacting with the Food and Drug Administration and other global regulatory bodies.
Hector’s work experience includes over 24 years contributing, managing, and leading in various roles as a member of quality organizations with major pharmaceutical and medical device companies. He also has 15 years of experience working as an independent consultant within this industry in the USA, Europe, India and the Americas.
Hector holds a degree in Biology with master’s degrees in Biochemistry and Molecular Biology. He particularly enjoys being a mentor and guide for those wishing to improve patient lives through the work they do.