Led comprehensive regulatory oversight for the organization, ensuring compliance and regulatory resilience with FDA, CAP/CLIA, HIPAA, OIG, DOJ, CMS, and OSHA regulations, while fostering an ethically compliant and morally responsible culture. Expertly developed risk-based Quality Management Systems in alignment with medical device and laboratory-developed test regulations. Proactively chaired Data Privacy & Cybersecurity and Executive Compliance Committees, overseeing annual risk assessments, vulnerability reports, process monitoring, regulatory inspections and audits. Established impactful compliance training programs for critical regulations such as FDA QSR, HIPAA Privacy and Security, Stark Law, False Claims Act, Anti-Kickback Statute, and CMS Fraud Waste and Abuse.

Expertise in • FDA Medical Device Quality System Management • Effective and Sustainable Corrective / Preventive Improvement Processes • Medical Device Reporting Requirements • Product & Shipping Complaint Investigation & Feedback Systems • Management of Nonconforming Product and Processes • Lean Manufacturing • Cost of Quality Improvements in Operations • Supplier Quality System & Process Development • Internal and External Auditing to MDSAP, ISO 13485:2016, JPAL, CMDCAS, MDD, FDA Medical Device 21CFR820 & Drug 21CFR210,211 and Health Canada Medical Device & Drug regulations.Responsibilities include the oversight and compliance to regulatory standards related to FDA Medical Device, OTC Drug, Health Canada Device & Drug, EPA and Medical Device Directive as well as the strategic quality system development of six manufacturing sites across North America. Development of robust compliance standards through the implementation of harmonized quality system processes within existing facilities as well as acquisitions. Responsible for the management of strategic corporate, measurable quality objectives used to demonstrate compliance to applicable regulatory standards and to demonstrate focused improvements in product quality, customer satisfaction.Report directly to the Vice President of Quality Assurance for Sybron Dental Specialties

Also held positions of QA Technical Coordinator, QA Associate ChemistResponsible for the receipt, sampling, and testing of chemical raw material ingredients used in the production of dental impression materials, temporary crown & bridge cements, casting materials, dental amalgam, and various dental laboratory solutions and solvents.Managed the product stability program.Performed all investigations, reviewed and/or performed testing, developed and evaluated trends for the product complaint process, include customer feedback and MDR reviews.Developed and programmed interactive Access Databases for product complaints, nonconforming materials, and critical material shortages.