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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
The Director of Quality reports to the Vice President of Quality Operations and Patient Safety and is responsible for the development, direction and effective implementation of a comprehensive hospital-wide infection control program, performance improvement, peer review program, outcomes management ,external reporting and patient safety systems. Key performance components include: 1. Clinical process improvement and team management across all HMH depts. 2. Lead all CMPI direction in collaboration with VP, CQO and AQOs. 3. Expertise in Data/information management, protection, presentation and benchmarking. 4. DNV and other regulatory compliance for quality of care. 5. Registry oversite, budgeting and staffing for quality improvement and operational efficiencies. 6. Support departmental quality resources as entity expert and partner. 7. Participate with system quality leadership to gain competency and effectiveness in organization wide initiatives as prescribed in strategic plan. 8. Organizational leadership, change management and culture education as key components of all PI and Patient Safety duties and deliverables.
EDUCATION REQUIREMENTS Graduate of accredited Bachelor's degree nursing program; Masters Degree in Nursing, or relevant Healthcare degree with experience in Healthcare Quality and Outcomes Management.
EXPERIENCE REQUIREMENTS At least 10 years of total relevant experience including at least: Three to five years clinical hospital/hospital operations experience. Five or more years hospital Performance Improvement experience. Three or more years management experience in directing a complex hospital-wide Performance Improvement program. Experience with regulatory surveys preparation and coordination
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED Certified Professional in Healthcare Quality preferred. Six Sigma certification desired. Current Texas RN license
Since its founding in 1919, Houston Methodist Hospital has earned worldwide recognition. Houston Methodist Hospital is affiliated with the Weill Medical College of Cornell University and New York-Presbyterian Hospital, one of the nation's leading centers for medical education and research. Houston Methodist is consistently ranked in U.S. News & World Report’s “Best Hospital” list and was recently... named the number one hospital in Texas. FORTUNE magazine has placed Houston Methodist on its annual list of “100 Best Companies To Work For” since 2006. Houston Methodist Hospital directs millions of research dollars into patient care and offers the latest innovations in medical, surgical and diagnostic techniques. With 1,119 licensed beds, 67 operating rooms and over 6,000 employees, Houston Methodist offers complete care for patients from around the world.