Clinical Quality Assurance Specialist jobs in United States
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Merit Medical Systems, Inc. · 12 hours ago

Clinical Quality Assurance Specialist

Merit Medical Systems, Inc. is dedicated to creating innovative medical devices that improve lives. The Clinical Quality Assurance Specialist will perform diversified clinical engineering responsibilities, ensuring compliance with regulatory standards and providing clinical support for product complaints and development.

Health CareManufacturing
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H1B Sponsor Likelynote

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

Qualification

Clinical Quality AssuranceRegulatory standards knowledgeMedical device experienceAnalytical problem solvingReport writingComputer skillsNC/CAPA knowledgeInterpersonal skillsCommunication skillsOrganizational skills

Required

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

Preferred

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

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As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care.

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 Company
Total Funding
$1.07B
Key Investors
Starboard Value
2023-06-07Post Ipo Debt· $850M
2020-01-14Post Ipo Equity
2018-07-31Post Ipo Equity· $217M

Leadership Team

N
Neil Peterson
Chief Operating Officer
R
Robert D. Poser
Vice President, Technology
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Company data provided by crunchbase