Clinical Quality Assurance Specialist

Clinical Quality Assurance Specialist

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.

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.

Preferred Qualifications

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