Clinical Quality Assurance Specialist

Merit Medical Systems, Inc.; South Jordan (UT); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in medical devices is seeking a Clinical Engineer to ensure compliance with quality standards and provide clinical support. The role involves collaboration with clients, managing complaints, and contributing to product development. Candidates should have a scientific background and strong problem-solving skills.

Benefits

Comprehensive insurance

Onsite medical clinic

Paid time off

401K

Health Savings Account

Qualifications

• At least five years of hands-on medical experience, preferably with medical devices.
• Ability to analyze and solve complex issues independently.

Responsibilities

• Ensure compliance with company procedures and regulatory standards.
• Consult with staff regarding clinical use of products.
• Manage complaint Nonconformances and Corrective Actions.

Skills

Communication

Problem solving

Interpersonal skills

Customer service understanding

Education

Bachelor's degree in a scientific or related discipline

Tools

Computer literacy

Job description

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. We aim to hire and develop individuals eager to build something exceptional through dedication, teamwork, and commitment. Together, we make a difference in patients' lives worldwide.

WORK SHIFT

DAY (United States of America)

SUMMARY OF DUTIES

The Clinical Engineer performs diversified responsibilities within the Global Quality / Field Assurance Department. They collaborate with internal and external clients to ensure proper handling and documentation of reported complaints, evaluate complaints, and apply Adverse Event determination criteria to make Vigilance Reporting decisions.

ESSENTIAL FUNCTIONS

1. Ensure compliance with company procedures (GP, GPS, QSP, etc.) and regulatory standards (FDA, CFR, MDR, ISO, etc.).
2. Consult with staff regarding clinical use of products and provide input for new product development.
3. Collaborate with Sales Representatives and customers to clarify clinical information related to complaints.
4. Respond to customer calls to gather clinical details.
5. Provide clinical training on complaint system requirements to employees and customers.
6. Build relationships and confidence among lab staff, physicians, Sales Reps, and clients.
7. Document clinical details of customer complaints.
8. Participate in meetings to determine notification requirements for regulatory authorities.
9. Support and troubleshoot product issues in the field, providing clinical feedback.
10. Supervise technicians or assistants as needed.
11. Manage complaint Nonconformances (NCs) and Corrective and Preventive Actions (CAPA), investigating and resolving issues.
12. Implement actions to prevent recurrence of nonconforming components or devices.
13. Identify and record product, process, and quality system problems.
14. Provide clinical input on investigation methods and experiments.
15. Contribute clinical insights to CRA, HSA, and FMEA development.
16. Draft documents addressing complaints, investigations, or reports requiring clinical input.
17. Present at or attend meetings that require clinical expertise.
18. Perform other related duties as necessary.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting not to exceed 50 lbs (local practices may vary).
• Writing, sitting, standing, bending, visual acuity, color and depth perception, reading, and field of vision.

MINIMUM QUALIFICATIONS

• Bachelor's degree in a scientific or related discipline or equivalent experience.
• At least five years of hands-on medical experience, preferably with medical devices.
• Excellent communication, interpersonal, organizational skills; detail-oriented; effective team player.
• Strong customer service understanding.
• Ability to analyze and solve complex issues independently.
• Knowledge of medical device use.
• Proficiency in computer skills, including spreadsheets, word processing, and databases.

PREFERRED QUALIFICATIONS

• Clinical experience or education equivalent to a Registered Nurse or Certified Cardiovascular/Interventional Radiologic Technologist.

CORE COMPETENCIES

• Product troubleshooting
• Interpersonal, communication, organizational skills
• Computer literacy
• Report writing
• Handling NC/CAPA causes and corrective actions
• Problem solving

COMMENTS

This role involves exposure to blood or body fluids, classified as Risk Category I.

EMPLOYEE BENEFITS AND CULTURE

Eligible employees can access multiple shift options, comprehensive insurance, onsite medical clinic, cafeterias, employee garden, paid time off, 401K, and Health Savings Account. For more about our culture, visit www.merit.com/careers.

Military veterans are encouraged to apply. Merit is a proud Utah Patriot Partner committed to hiring veterans.