256A - Quality Assurance Auditor I (Annual)

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.

SUMMARY OF DUTIES

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
 

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:
•    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

Willingness to work in shifts.

 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.

We are Global

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer 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 an international sales force and clinical support team totalling in excess of 500 individuals. Merit employs approximately 6,300 people worldwide.

Merit Medical EMEA currently has over 300 employees, spread over more than 20 countries in the EMEA region.

Merit Maastricht (The Netherlands) is the European Headquarters and Distribution Center of Excellence. Much of Merit Medical’s world-class customer service happens here along with our excellent physician training courses. More than 100 employees work at this growing Merit campus and enjoy many benefits, such as flexible working hours and competitive salaries as well as learning opportunities and internships.

Culture

A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with a 50/50 ratio of male and female employees and more than 30 nationalities. We value every employee as an individual.

To see more on our culture, go to www.merit.com/careers.