Quality Assurance Technician II - Part Time (Fixed-Term)

Regulatory Jobs

South Jordan (UT)

In loco

USD 40.000 - 60.000

Tempo pieno

2 giorni fa

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Medical/Dental & Other Insurances

Low Cost Onsite Medical Clinic

Onsite Cafeterias

3 Weeks Vacation / 1 Week Sick-Time

Descrizione del lavoro

Merit Medical seeks a Quality Assurance Technician/Intern to assist Post Market Surveillance and Recall/Field Action teams in a regulated medical device environment. This fixed-term role covers quality system documentation, data entry, and record maintenance, with duties spanning inspection support, traceability, and customer response tracking.

The position runs through March 2027 and involves multiple shift options on DAY hours in the United States.

Competenze

The role requires a foundation in quality systems and documentation practices.
Experience with regulated recordkeeping and document control is preferred.
Familiarity with eQMS, ERP, and recall tracking is a plus.

Mansioni

Maintain quality records and support document control requirements.
Assist with data entry, filing, indexing, and organization of quality system records.
Support recall coordination and administrative execution of recalls and field actions.
Enter and verify information in quality databases and tracking systems.
Assist with inspection-ready documentation and product traceability.

Conoscenze

Excellent organizational skills

Interpersonal skills

Attention to detail

Written and verbal communication

Team player

Independent work ability

Multitasking in a regulated, deadline‑

Formazione

Associate degree in technical/scientific/regulatory field

High school diploma or equivalent

Strumenti

Excel

Word

Outlook

eQMS

ERP systems

Descrizione del lavoro

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

The 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 elevate 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 elevate 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 support

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

Lifting – Not to exceed 50 lbs. – local practice may apply.
Writing
Sitting
Standing
Vision; computer screen
Reading

COMPETENCIES

Project team participation

COMMENTS

Infectious 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: