Merit Medical Systems

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.

This listing is sourced directly from Merit Medical Systems's careers page and normalized into a canonical job model.