EDUCATION

BSME – Manufacturing Engineering, National University,

Sacramento, CA

BSLME – Logistics / Engineering Management,

Weber State University, Ogden, UT

EXPERIENCE

Executive responsibility for leading the corporate quality management system including the setting of quality goals, managing, and improving all aspects of the quality system with an emphasis on regulatory compliance, customer experience, design controls, production controls and process performance, risk management and quality management to ensure compliance to drive measurable improvement in product safety and efficacy. Lead the corporate culture transformation efforts with respect to quality by successfully developing and providing Regulatory and Quality Systems training.

Work with executive, marketing, and the operations teams, human resources, and others to ensure that customer measures and Voice of Customer input is appropriately reflected into all internal policies, practices, and processes to include all development, operations and customer facing roles. Provide global strategic experience in Regulatory Affairs, Compliance, FDA submissions and global submission strategy. Complete technical files / design dossiers and review clinical trials / studies to compile clinical evaluation reports in support of MDR new and transition listings for TracPatch medical devices. Establish notified bodies and in country representatives to support international medical devices entries and required quality management system structures.

VALUE STATEMENT

This team member is responsible for identifying opportunities, fostering strong client relationships, and directing regulatory paths that meet client needs. These responsibilities include the direction of projects and includes the responsibility to ensure the team and products are meeting quality, regulatory and organizational targets while navigating the fast- paced world of Regulatory Affairs and Quality Assurance.

CERTIFICATIONS / QUALIFICATIONS

ASQ – Certified Manager of Quality / Operational Excellence

ASQ – Certified Quality Auditor

AAMI – Quality System Auditor: 21 CFR Part 820 Federal Quality System Regulation

QAC – Certified Six Sigma Master Black Belt