Clinical Quality Assurance Specialist – Fixed-Term

This is a fully remote position, open to applicants in Utah.

📋 Description

• Ensures adherence to company protocols (GP, GPS, QSP, etc.) and regulatory requirements (FDA, CFR, MDR, ISO, etc.) relevant to designated responsibilities.

• Collaborates with Merit staff regarding the application of products in clinical environments by healthcare professionals, offering clinical insights for the design and development of new products.

• Works alongside Sales Representatives and customers to clarify and enhance understanding of clinical information concerning reported product issues.

• Handles incoming customer inquiries to gather clinical information.

• Delivers clinical training for employees and customers on the requirements of the complaint system.

• Establishes and nurtures relationships to build trust among laboratory personnel, physicians, Sales Representatives, and other Merit clients.

• Ensures accurate documentation of clinical details related to customer complaints.

• Participates in meetings to assess which events/incidents necessitate notification to regulatory bodies.

• Prepares and submits reports of adverse events to regulatory authorities.

• May oversee the work of technicians or others involved in associated tasks.

• Accountable for addressing complaint Nonconformances (NCs) and Corrective Preventive Actions (CAPA), investigating, resolving issues, and determining further actions.

• Initiates and/or executes measures to prevent the recurrence or use of nonconforming components, manufacturing materials, or finished products.

• Identifies and documents any issues related to products, processes, and quality systems.

• Provides clinical insights and approves investigation methodologies and experiments.

• Offers clinical perspectives on complaints during the development of CRA, HSA, and FMEA.

• Drafts documents addressing complaints, investigations, or reports requiring clinical insight.

• Presents at and/or attends local, regional, and national meetings that require clinical expertise, knowledge, and experience.

• Performs additional duties and tasks as necessary.

⛳️ Requirements

• Education and/or experience equivalent to a Bachelor's degree in a scientific discipline or related field.

• At least five years of practical medical experience, preferably in the medical device sector.

• Exceptional communication, interpersonal, and organizational skills, with a keen eye for detail and the ability to work efficiently as part of a team.

• Comprehensive understanding of customer service practices.

• Capability to independently employ analytical and problem-solving skills to comprehend and address complex challenges.

• Familiarity with the usage of medical products/devices.

• Proven expertise in computer applications, ideally including spreadsheets, word processing, database management, and other relevant software programs.

🏝️ Benefits

• Multiple Shifts and Hours available: Days, Swing (Evening), and Nights

• Medical/Dental and Other Insurances (eligible from the first of the month after 30 days)

• Affordable Onsite Medical Clinic

• Two (2) Onsite Cafeterias

• Employee Garden | Gardening Classes

• 3 Weeks' Vacation | 1 Week Sick Time | Paid Holidays

• 401K | Health Savings Account