Clinical Quality Assurance Specialist (Fixed-Term)

Work Shift: DAY Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. This position is a fixed-term opportunity currently expected to run through March 2027.

ESSENTIAL FUNCTIONS PERFORMED

Ensures that company procedures (GP, GPS, QSP, etc.) and regulatory standards (FDA, CFR, MDR, ISO, etc.) are followed with respect to assigned areas of responsibility. Consults with Merit staff regarding the use of products in a clinical setting by clinicians. Provides clinical input for new product design and development. Works with Sales Representatives and customers to clarify, obtain, and/or better understand the clinical information in relation to reported product complaints. Answers incoming customer calls to collect clinical information. Provides clinical training to employees and customers on the complaint system requirements. Establishes relationships and builds confidence among lab staff, physicians, Sales Representatives, and other Merit customers. Ensures clinical details involving customer complaints are documented. Attends meetings to help determine which events/incidents require notification to regulatory authorities. Creates and submits reportable adverse events to regulatory agencies. May supervise the work of technicians or others who assist in related assignments. Is responsible for complaint Nonconformances (NC's) and Corrective Preventive Actions (CAPA) and investigates, resolves issues and determines course of action. Initiates and/or implements action to prevent occurrence or use of nonconforming components, manufacturing materials or finished devices. Identifies and records any product, process and quality system problems. Provides clinical input on and approves investigation methods and experiments. Provides clinical input from a complaint perspective on CRA, HSA and FMEA development. Writes documents to address complaints, investigations, or reports requiring clinical input. Makes presentations at and/or attends local, regional, and national meetings requiring clinical expertise, knowledge, and experience. Performs other duties and tasks as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

Lifting – Not to exceed 50 lbs. – local practice may apply. Writing Sitting Standing Bending Visual acuity Color perception Depth perception Reading Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

Education and/or business experience equivalent to a Bachelor's degree in a scientific discipline or related area. A minimum of five years of hands‑on medical experience, preferably with medical devices. Excellent communication, interpersonal, and organizational skills, detail oriented, and the ability to work effectively as a team member. A thorough understanding of customer service practices. Ability to independently apply analytical and problem‑solving skills to understand and solve complex issues. Knowledge of medical product/device use. Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.

PREFERRED QUALIFICATIONS

Education and/or clinical experience equivalent to a Registered Nurse or Certified Cardiovascular or Interventional Radiologic Technologist.

COMPETENCIES

Product trouble shooting Interpersonal/communication/organizational skills Computer skills Report writing NC/CAPA causes/corrective actions/dispositions Problem solving

COMMENTS

Infectious Control Risk Category I: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category I states employment and procedures that will require exposure. As an eligible Merit employee, you can expect the following: Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights Medical/Dental & Other Insurances (eligible the first of month after 30 days) Low Cost Onsite Medical Clinic Two (2) Onsite Cafeterias Employee Garden | Gardening Classes 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays 401K | Health Savings Account To see more on our culture, go to Military Veterans are encouraged to Apply. Merit is a proud Utah Patriot Partner committed to hiring our Veterans. #J-18808-Ljbffr Merit Medical Systems, Inc.