Clinical Quality Assurance Specialist

Merit Medical Systems, Inc.•South Jordan, UT

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.
Consult 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.
Establish 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.
Works in the field to support and troubleshoot product related issues and provide clinical feedback to resolve customer questions and/or concerns.
May supervise the work of technicians or others who assist in related assignments.
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.
Provide clinical input on and approve investigation methods and experiments.
Provide clinical input from a complaint perspective on CRA, HSA and FMEA development.
Write 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.