Merit Medical Systems, Inc. · 6 hours ago
Clinical Quality Assurance Specialist
South Jordan, UT
Full-time
Onsite
Senior Level
5+ years expMerit Medical Systems, Inc. is dedicated to creating innovative medical devices that improve lives. They are seeking a Clinical Quality Assurance Specialist to perform diversified clinical engineering responsibilities, ensuring compliance with regulatory standards and providing clinical training related to product complaints.
Health CareManufacturing
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
Consults with Merit staff regarding the use of products in a clinical setting
Works with Sales Representatives and customers to clarify, obtain, and/or better understand the clinical information in relation to reported product complaints
Performs follow-up in the form of emails or calls to obtain additional clinical information relating to product complaints
Provides clinical training to employees and customers on the complaint system requirements
Establishes relationships and builds confidence among 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 closely with other Clinical Quality Assurance Specialist or others who assist in related assignments
Assists in Corrective Preventive Actions (CAPA); including investigations and resolving issues and determining 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, or quality system problems
Provides clinical input on and may approve investigation methods and experiments
Writes documents to address complaints, investigations, or reports requiring clinical input
Assists in tracking and managing regulatory requests for additional information in relation to product complaints and adverse events
Performs a variety of other tasks and related work, as required
Qualification
Required
Education and/or business experience equivalent to a Bachelor's degree in a scientific discipline or related area
Education and/or clinical experience equivalent to a Registered required
A minimum of five years of hands-on medical experience, preferably with medical devices
Knowledgeable in reporting on Adverse Events and Vigilance reports
Thorough understanding of customer service practices
Ability to independently apply analytical and problem solving skills to understand and solve complex issues
Knowledge of NC/CAPA causes/corrective actions/disposition
Demonstrated experience with report writing
Knowledge of medical product/device use
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
Preferred
Cardiac, GI, Medical Surgical, or Operating room clinical experience preferred
Benefits
Medical/Dental & Other Insurances (eligible the first of month after 30 days)
Low Cost Onsite Medical Clinic
Two (2) Onsite Cafeterias
Employee Garden | Gardening Classes
3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
401K | Health Savings Account
Company
Merit Medical Systems, Inc.
As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care.
5001-10000 employees
H1B Sponsorship
Merit Medical Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2022 (4)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.07BKey Investors
Starboard Value
2023-06-07Post Ipo Debt· $850M
2020-01-14Post Ipo Equity
2018-07-31Post Ipo Equity· $217M
Leadership Team
Martha Aronson
President and Chief Executive Officer
N
Neil Peterson
Chief Operating Officer
Recent News
BioWorld Financial Watch
2026-01-11
Columbia West
2025-12-13
Company data provided by crunchbase