Merit Medical Systems
Clinical Quality Assurance Specialist (Fixed-Term)
Utah - Virtual, USA
Sponsorship not specifiedDetected 5 days ago
Customer SupportFDA RegulatoryMedical DevicesCommunicationProblem SolvingPublic SpeakingOrganizational Skills
About the role
- Work Shift: DAY Work Schedule: Why Merit?
- This position is a fixed-term opportunity currently expected to run through March 2027.
- 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.
Responsibilities
- Provides clinical input for new product design and development.
- Establish relationships and builds confidence among lab staff, physicians, Sales Representatives, and other Merit customers.
- Creates and submits reportable adverse events to regulatory agencies.
- Initiates and/or implements action to prevent occurrence or use of nonconforming components, manufacturing materials or finished devices.
- Write documents to address complaints, investigations, or reports requiring clinical input.
Requirements
- Excellent communication, interpersonal, and organizational skills, detail oriented, and the ability to work effectively as a team member.
- Ability to independently apply analytical and problem solving skills to understand and solve complex issues.
- Performs other duties and tasks as required.
Nice to have
- Product trouble shooting
- Interpersonal/communication/organizational skills
- NC/CAPA causes/corrective actions/dispositions
- 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
Benefits
- Provide clinical input from a complaint perspective on CRA, HSA and FMEA development.
- Field of vision/peripheral
- Medical/Dental & Other Insurances (eligible the first of month after 30 days)
- Low Cost Onsite Medical Clinic
Company info
- Works with Sales Representatives and customers to clarify, obtain, and/or better understand the clinical information in relation to reported product complaints.
- Provides clinical training to employees and customers on the complaint system requirements.
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This listing is sourced directly from Merit Medical Systems's careers page and normalized into a canonical job model.