256H - Quality Assurance Auditor I (Hourly)

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.