Quality Compliance Specialist
merit medicalSouth Jordan (UT)
Quality Compliance Specialist
Posted 2 days ago
merit medicalSouth Jordan (UT)
SENIORITY
Senior
About the role
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 SHIFTDAY (United States of America)SUMMARY OF DUTIESThe Quality Assurance Technician/Intern is a lower-level supporting role responsible for assisting Post Market Surveillance and Recall/Field Action personnel with quality system documentation, product tracking, inspection support, data entry, record maintenance, and administrative execution of quality and recall-related activities within a regulated medical device environment. This position is a fixed-term opportunity currently expected to run through March 2027.
ESSENTIAL FUNCTIONS: PERFORMED
- Maintain accurate and complete quality records in accordance with approved procedures and document control requirements.
- Assist with data entry, filing, indexing, and organization of quality system records.
- Support review of records for completeness, accuracy, legibility, and traceability.
- Assist with maintaining controlled forms, logs, trackers, and department databases.
- Ensure documentation is maintained in an inspection-ready state.
- Support Recall Coordinators with administrative execution of product recalls, corrections, removals, advisory notices, and field actions.
- Assist with customer response tracking, effectiveness check documentation, and follow-up logs.
- Compile and organize recall correspondence, return documentation, certificates of destruction, and related objective evidence.
- Maintain recall trackers and escalate overdue or incomplete responses to the assigned Recall Coordinator.
- Support reconciliation of affected product, returned product, destroyed product, and customer acknowledgments. Inspection, Product Evaluation, and Sample Handling
- Perform or assist with visual inspections, returned product checks, sample labeling, and basic product documentation under supervision.
- Document inspection observations clearly and accurately using approved forms and procedures.
- Support containment, segregation, and tracking of returned or nonconforming product as directed.
- Assist with maintaining chain of custody, traceability, and storage of product samples or returned devices.
- Enter and verify information in quality databases, spreadsheets, eQMS platforms, or other tracking systems. SUMMARY OF MINIMUM QUALIFICATIONS
- Excellent organizational and interpersonal skills.
- Ability to work well as a team member.
- Associate degree in a technical, scientific, quality, regulatory, or related field preferred; equivalent industry experience may be considered in lieu of degree.
- High school diploma or equivalent required.
- 1–3 years of experience in medical device, pharmaceutical, biotechnology, manufacturing, laboratory, quality assurance, document control, or another regulated industry preferred.
- Basic understanding of quality systems, Good Documentation Practices, traceability, and regulated recordkeeping preferred.
- Experience with Microsoft Office, especially Excel, Word, and Outlook.
- Experience with eQMS, ERP, complaint handling, recall tracking, or document control systems preferred but not required. Required Skills and Competencies
- Strong attention to detail and ability to follow written procedures accurately.
- Good written and verbal communication skills.
- Ability to organize records, manage trackers, and maintain accurate documentation.
- Basic problem-solving skills and ability to identify missing, inconsistent, or incomplete information.
- Ability to work independently on routine assignments and escalate issues appropriately.
- Ability to support multiple priorities in a regulated, deadline-driven environment. Key Performance Indicators (KPIs )
- Accuracy and completeness of quality records
- Timeliness of data entry and tracker updates
- Customer response and effectiveness check tracking supportESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
- Lifting – Not to exceed 50 lbs. – local practice may apply.
- Writing
- Sitting
- Standing
- Vision; computer screen
- ReadingCOMPETENCIES
- Project team participationCOMMENTSInfectious Control Risk Category II: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 II states employment and procedures that may 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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