Quality Assurance Auditor I

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

Responsible for auditing medical products to ensure that they have been manufactured according to Merit’s policies, procedures, specifications and standards. Also audits the system by which product is produced.

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 complex testing equipment in verifying that final product meet specification.
•    Performs dimensional inspections.
•    Initiates and makes copies of final inspection paperwork.
•    Performs product transfers as applicable.
•    Tracks and maintains NC's and material testing products.
•    Submits materials for MEM/IR testing.
•    Performs specification training for production employees.
•    Quarantines product when discrepancies are noted.
•    Performs work order close-outs.
•    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 and a minimum of two years of related work experience with one of the years being in quality assurance/quality control work 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.
•    Communication and interpersonal skills and the ability to work well with others.
•    Demonstrates the ability to operate complex test equipment.
•    Able to perform all Quality Assurance Auditor functions for one of the following areas:
•    Clean Room
•    Molding
•    Label Control
•    IQA

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
•    Complex testing equipment operation
•    Work order close-outs/sign-offs
•    Material testing products/NC tracking, maintenance, labeling
•    Auditor training
•    Dimensional inspection
•    Systems auditing

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.

Military Veterans are encouraged to Apply.

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