Quality Assurance Auditor

Overview

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.

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.

• 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 they conform with Device History Records/applicable specifications 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 meets 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.

• 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

• 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

• 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

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.

• 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 onsite cafeterias.
• Employee garden and gardening classes.
• 3 weeks vacation.
• 1 week sick time.
• Paid holidays.
• 401K.
• Health Savings Account.