Clinical Quality Assurance Specialist

100 Merit Medical Systems, Inc.; South Jordan (UT); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading company in the medical device industry is seeking a Clinical Quality Assurance Specialist to ensure compliance with regulatory standards and enhance product quality. This role will involve evaluating complaints, providing clinical training, and collaborating closely with internal and external stakeholders. Ideal candidates will have a scientific background, significant medical experience, and strong interpersonal skills.

Benefits

Medical/Dental & Other Insurances

401K | Health Savings Account

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

Onsite Cafeterias

Qualifications

• Five years of hands-on medical experience, preferably with medical devices.
• Ability to independently apply analytical and problem-solving skills.
• Knowledge of medical product/device use.

Responsibilities

• Ensure company procedures and regulatory standards are followed.
• Evaluate complaints and apply Adverse Event determination criteria.
• Provide clinical input for new product design and development.

Skills

Communication

Problem-solving

Interpersonal skills

Organizational skills

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office Suite

Job description

Clinical Quality Assurance Specialist page is loaded

Clinical Quality Assurance Specialist

Apply locations South Jordan, UT All US time type Full time posted on Posted 23 Days Ago job requisition id JR112747

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

WORK SHIFT

DAY (United States of America)

SUMMARY OF DUTIES

Performs diversified clinical engineering responsibilities in the Global Quality / Field Assurance Department. Works with internal and external customers to ensure proper handling and documentation of reported complaints. Evaluates complaints and applies Adverse Event (AE) determination criteria in order to make Adverse Event and Vigilance Reporting decisions.

ESSENTIAL FUNCTIONS PERFORMED

1. 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.
2. Consult with Merit staff regarding the use of products in a clinical setting by clinicians. Provides clinical input for new product design and development.
3. Works with Sales Representatives and customers to clarify, obtain, and/or better understand the clinical information in relation to reported product complaints.
4. Answers incoming customer calls to collect clinical information.
5. Provides clinical training to employees and customers on the complaint system requirements.
6. Establish relationships and builds confidence among lab staff, physicians, Sales Representatives, and other Merit customers.
7. Ensures clinical details involving customer complaints are documented.
8. Attends meetings to help determine which events/incidents require notification to regulatory authorities.
9. Works in the field to support and troubleshoot product related issues and provide clinical feedback to resolve customer questions and/or concerns.
10. May supervise the work of technicians or others who assist in related assignments.
11. Responsible for complaint Nonconformances (NC’s) and Corrective Preventive Actions (CAPA) and investigates, resolves issues and determines course of action.
12. Initiates and/or implements action to prevent occurrence or use of nonconforming components, manufacturing materials or finished devices.
13. Identifies and records any product, process and quality system problems.
14. Provide clinical input on and approve investigation methods and experiments.
15. Provide clinical input from a complaint perspective on CRA, HSA and FMEA development.
16. Write documents to address complaints, investigations, or reports requiring clinical input.
17. Makes presentations at and/or attends local, regional, and national meetings requiring clinical expertise, knowledge, and experience.
18. Performs other duties and tasks as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting -- Not to exceed 50 lbs. – local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

• 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 QUALIFICATIONS

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

COMPETENCIES

• Product trouble shooting
• Interpersonal/communication/organizational skills
• Computer skills
• Report writing
• NC/CAPA causes/corrective actions/dispositions
• Problem solving

COMMENTS

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

* 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

To see more on our culture, go to www.merit.com/careers .

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.

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About US

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

UNDERSTAND. INNOVATE. DELIVER.

Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit has made it a priority to understand customers, innovate, and deliver life-changing products and services.