256H - Quality Assurance Auditor I (Hourly)

Posted Yesterday
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Richmond, VA, USA
In-Office
Junior
Healthtech • Other • Biotech
The Role
Perform audits of production and finished medical products to verify compliance with Device Master Record/QSR/GMP. Generate, document, and close nonconformances (NCs), complete final inspection paperwork, review work orders/ECNs, segregate discrepant product, and operate basic test equipment to confirm product meets specifications.
Summary Generated by Built In

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

SUMMARY OF DUTIES

This position is responsible for auditing medical products to ensure that they have been manufactured according to Merit’s policies, procedures, specifications and standards.

ESSENTIAL FUNCTIONS PERFORMED

•    Generation and distribution of NC’s for specific area -- QAP’s and MPS’s.
•    Audits the production process to confirm that Device History Records are completed according to Device Master Record/QSR/GMP regulations.
•    Audits finished products to ensure that it conforms with Device History Records/applicable specification and procedures.
•    Completes final inspection paperwork.
•    Performs work order reviews for ECN's, EPWO's, NC's, etc.
•    Documents inspections/rejections on inspection paperwork.
•    Segregates product when discrepancies are noted.
•    Initiates and ensures closure of NC’s.
•    Accountable for the disposition agreement/verification of NC’s.
•    Initiates, identifies (labels) and ensures closure of NC’s.  Enters information into NC database.
•    Operates basic testing equipment in verifying that final product meet specification.
•    Performs other related quality auditing tasks, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

•    Lifting -- up to 50 lbs
•    Writing
•    Sitting
•    Standing
•    Bending
•    Vision
•    Color perception
•    Depth perception
•    Reading
•    Field of vision/peripheral
•    Fine motor skills
•    Noise
•    Chemical vapors
•    Soldering fumes

 
SUMMARY OF MINIMUM QUALIFICATIONS

•    Education and experience equivalent to a High School Diploma with a minimum of one year of related experience.
•    Demonstrated knowledge of business mathematics.
•    Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
•    Excellent attention to detail and the ability to meet deadlines in a timely manner.
•    Ability to learn to operate basic test equipment.
•    Communication and interpersonal skills and the ability to work well with others.

COMPETENCIES

•    Production process auditing for specific and general area -- PPS’s, QAP’s, MPS’s, and GPS’s
•    Finished product auditing
•    Basic test equipment operation.
•    Final inspection paperwork
•    Work order reviews
•    Product final inspection
•    Generation and distribution of NC’s
•    Specification training

COMMENTS

Infectious Control Risk Category III:

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 III states employment and procedures that do not 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.

Skills Required

  • High School Diploma or equivalent
  • Minimum of one year related experience
  • Demonstrated knowledge of business mathematics
  • Computer skills (spreadsheets, word processing, databases)
  • Excellent attention to detail and ability to meet deadlines
  • Ability to learn and operate basic test equipment
  • Communication and interpersonal skills
  • Ability to lift up to 50 lbs and perform physical tasks (standing, bending)
  • Color and depth perception and fine motor skills

Merit Medical Systems, Inc. Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Merit Medical Systems, Inc. and has not been reviewed or approved by Merit Medical Systems, Inc..

  • Healthcare Strength An on‑site medical clinic at headquarters and campus wellness initiatives aim to make care more convenient and affordable for employees and families. Safety training and ongoing wellness programming further reinforce the health offering.
  • Retirement Support A 401(k) Profit Sharing Plan with active employer contributions and discretionary matching provides structured support for long‑term savings. Eligibility and plan participation are clearly established for U.S. employees.
  • Equity Value & Accessibility An employee stock purchase plan with a purchase discount enables accessible ownership participation. A successor plan is slated to replace the legacy program, pending shareholder approval.

Merit Medical Systems, Inc. Insights

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The Company
HQ: South Jordan, UT
5,001 Employees
Year Founded: 1987

What We Do

As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care. Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution 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 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

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