Responsible for providing regulatory and quality assurance leadership, guidance and strategy including the establishment of a quality management system, and the management, preparation, and submission of regulatory filings. Responsible for developing strategies/timelines, conducting meetings, and acting as a liaison with relevant regulatory bodies and as a regulatory representative to clients.

Leadership responsibility for ensuring compliance with laws, regulations, and policies governing the operation of clinical and anatomic pathology laboratories.Compliance Officer responsible for the company compliance program, assuring continuous conformance with appropriate standards and regulations. Investigate, report, and recommend corrective actions for issues associated with Anti-kickback, Stark, HIPAA, PPACA, and other statutes and regulations. Review and approve physician client contracts.Management responsibility for Safety, Health, and Environmental management systems.

Leadership of the quality management system for all company-wide quality policies, procedures, processes, programs, and practices. Company liaison for all external client audits and accreditation inspections including developing, organizing, and submitting responses and corrective actions.Compliance Officer responsible for the company compliance program, assuring continuous conformance with appropriate standards and regulations. Investigate, report, and recommend corrective actions for issues associated with Anti-kickback, Stark, HIPAA, PPACA, and other statutes and regulations. Review and approve physician client contracts.Management responsibility for Safety, Health, and Environment management systems.Member Industry Advisory Panel Kansas BIOMember Public Policy Committee Kansas BIOMember Overland Park Chamber of Commerce Government Affairs CommitteeServed on the Editorial Advisory Board for the Journal of GXP Compliance.

Manage Quality and Technical Services team to meet and exceed customer expectations. Leadership responsibility for quality assurance and quality control activities for all products including the management of 3rd party product inspections for Asian suppliers. Ensure appropriate complaint investigation and resolution. Develop, implement and ensure compliance with required quality processes. Develop, implement and maintain ISO/TL 9000 certified Quality Management System. Previous direct and matrix management responsibility for driving customer satisfaction with Technical Support of IP and TDM business key systems.

Responsible for all aspects of operations including service, inventory control, purchasing and sustaining engineering for a leading custom test solutions provider to the avionics industry. Leadership responsibility for a team of 80+ employees with direct profit and loss responsibility for a $16 million business unit. Implemented numerous improvement initiatives in the areas of material cost reduction, inventory reduction and efficiency gains in manufacturing, PCB assembly and test.

Responsible for quality system implementation, management and compliance. Leadership responsibility for technical services and materials support of a business with sales of $8.5 mil growing at 10% + annually.