Program Manager, Quality Systems

WORK SHIFT DAY (United States of America) SUMMARY OF DUTIES This position manages and is responsible for managing the VIP program at Merit and multiple core business improvement projects to assure timely delivery of new or improved processes that meet user needs. The role includes timely completion of projects that meet or exceed performance goals, providing compliance guidance and quality operational support for manufacturing or distribution operations, services, and systems, collaborating with Quality Management to recommend, design, and implement functional process improvements, and developing, establishing, and maintaining quality methodologies, systems, and practices that meet company, customer, and regulatory requirements. The position interacts with and mentors internal cross‑functional groups as well as external customers. ESSENTIAL FUNCTIONS PERFORMED Manages VIP Program for Merit Medical and multiple core business improvement projects to assure timely delivery of new or improved processes which meet user needs. Creates, tracks, and meets project schedules, plans, and budgets across multiple Merit sites. May act as project leader or oversee project leader activities. Monitors work performed by assigned department staff and assists staff in working on team projects. Proactively and continuously improves internal systems and processes with a quality mindset. Acts as a subject matter expert (SME) and supports operational quality issues for manufacturing or distribution sites as applicable. Develops reports and conducts compilation of information for site and functional management. Collaborates with cross‑functional colleagues regarding the impacts of enhancements and process changes. Understands and adheres to current Quality System Regulations and all applicable regional regulations. Supports document updates and reviews. Communicates impact and drives resolutions with the stakeholders. Understands, interprets, and applies documentation control principles and processes to ensure compliance with the global quality system. Performs other related duties and tasks as required. ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS Lifting – not to exceed 50 lbs. Writing Sitting Standing Bending Visual acuity Color perception Depth perception Reading Field of vision/peripheral SUMMARY OF MINIMUM QUALIFICATIONS Education and/or experience equivalent to a bachelor’s degree in a scientific/engineering discipline. Eight (8) years of job‑relevant experience. Demonstrated computer skills, preferably spreadsheet, word processing, database, and other applicable software programs. Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per Global QA objectives. Demonstrated ability to independently function in a fast‑paced environment while moving multiple simultaneous projects forward. Demonstrated working knowledge of 21 CFR 820, ISO 13485, and other medical device related standards. PREFERRED QUALIFICATIONS Medical device industry knowledge strongly preferred. Certified Quality Auditor or Certified Quality Engineer by ASQ. Technical writing skills. COMPETENCIES Excellent interpersonal skills. Ability to resolve customer problems efficiently and effectively. Good organizational skills. Ability to work under strict time constraints to meet customer requirements. Strong oral and written communication skills. Excellent attention to detail and time management skills. Ability to work independently and with cross‑functional teams. Customer Service skills. Troubleshooting/negotiation skills. EEO Statement Merit is a proud Utah Patriot Partner committed to hiring our Veterans. Military Veterans are encouraged to apply. #J-18808-Ljbffr 100 Merit Medical Systems, Inc.