Clinical Quality Assurance Specialist

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. WORK SHIFT DAY (United States of America) SUMMARY OF DUTIES Performs diversified clinical engineering responsibilities in the Global Quality / Field Assurance Department. Works with internal and external customers to ensure proper handling and documentation of reported complaints. Evaluates complaints and applies Adverse Event (AE) determination criteria in order to make Adverse Event and Vigilance Reporting decisions. ESSENTIAL FUNCTIONS PERFORMED 1. 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. 2. Consults with Merit staff regarding the use of products in a clinical setting. 3. Works with Sales Representatives and customers to clarify, obtain, and/or better understand the clinical information in relation to reported product complaints. 4. Performs follow-up in the form of emails or calls to obtain additional clinical information relating to product complaints. 5. Provides clinical training to employees and customers on the complaint system requirements. 6. Establishes relationships and builds confidence among staff, physicians, Sales Representatives, and other Merit customers. 7. Ensures clinical details involving customer complaints are documented. 8. Attends meetings to help determine which events/incidents require notification to regulatory authorities. 9. Works closely with other Clinical Quality Assurance Specialist or others who assist in related assignments. 10. Assists in Corrective Preventive Actions (CAPA); including investigations and resolving issues and determining course of action. 11. Initiates and/or implements action to prevent occurrence or use of nonconforming components, manufacturing materials or finished devices. 12. Identifies and records any product, process, or quality system problems. 13. Provides clinical input on and may approve investigation methods and experiments. 14. Writes documents to address complaints, investigations, or reports requiring clinical input. 15. Assists in tracking and managing regulatory requests for additional information in relation to product complaints and adverse events. 16. Performs a variety of other tasks and related work, 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.
• Education and/or clinical experience equivalent to a Registered required.
• A minimum of five years of hands-on medical experience, preferably with medical devices.
• Knowledgeable in reporting on Adverse Events and Vigilance reports.
• Thorough understanding of customer service practices.
• Ability to independently apply analytical and problem solving skills to understand and solve complex issues.
• Knowledge of NC/CAPA causes/corrective actions/disposition.
• Demonstrated experience with report writing.
• Knowledge of medical product/device use.
• Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.

PREFERRED QUALIFICATIONS

• Cardiac, GI, Medical Surgical, or Operating room clinical experience preferred.

COMPETENCIES

• Interpersonal Skills
• Written and Verbal Communication
• Organization
• Problem solving
• Interpersonal Skills
• Teamwork

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 www.merit.com/careers. Military Veterans are encouraged to Apply. Merit is a proud Utah Patriot Partner committed to hiring our Veterans. Apply tot his job Apply To this Job