Quality Assurance Auditor I - Evenings

Merit-Medical-Systems-Inc.; South Jordan (UT); On-site; USD 52,000 - 78,000; Full time

Benefits offered by this job

Medical Insurance

Onsite Clinic

Cafeterias

Vacation

401K

Paid Holidays

Job summary

Merit Medical Systems, Inc. seeks a Quality Auditor to oversee the auditing of medical devices, ensuring compliance with Merit’s policies and GMP/QSR standards. The role involves generating NCs, auditing processes, and completing final inspection documentation.

Responsibilities include reviewing work orders, labeling and closing NCs, and maintaining accurate inspection records while upholding strict quality controls. Shift options include Days, Swing, and Nights.

Qualifications

• High School Diploma or equivalent with at least 1 year of related experience.
• Demonstrated knowledge of business mathematics and basic test equipment.
• Able to learn to operate basic testing equipment and use standard software programs.

Responsibilities

• Audit production processes to verify Device History Records align with Master Record/QSR/GMP.
• Generate and distribute nonconformances (NCs) for the specified area.
• Audit finished products for conformance to specs and procedures.
• Complete final inspection paperwork and review work orders (ECN/EPWO/NC).
• Enter NC information into database and ensure closure of NCs.”

Skills

Attention to detail

Computer skills

Communication

Teamwork

English proficiency

Education

High School Diploma

Tools

Spreadsheets

Word processing

Database software

Job description

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 SHIFTEVE (United States of America)SUMMARY OF DUTIESThis position is responsible for auditing medical products to ensure that they have been manufactured according to Merit’s policies, procedures, specifications and standards.SCHEDULE: Monday - Thursday 3:30pm - 2:00amESSENTIAL 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• English Fluency 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 fumesSUMMARY 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 trainingCOMMENTSInfectious 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 AccountTo 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.