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Merit Medical Systems, Inc.

Manufacturing Quality Assurance Engineer III

LocationSouth Jordan, UT
Work modeon-site
Typefull-time
SenioritySenior
Experience5+ yrs
Company size10,000+ people
First seenOct 5, 2026 · 6d ago
Verified live1d ago
At a glanceSummarised by Seekless from the posting.
Must have8
Bachelor's Degree in Chemistry or related field
Five years quality engineering experience
Strong interpersonal, organizational, and verbal and written communication skills
Ability to work effectively as a team member
Demonstrated working knowledge of 21 CFR 820, ISO 13485, ISO 14791, and other medical device related standards
Proven ability to work effectively in a team environment through conflict resolution and negotiations
Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc.
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
Nice to have4
Medical device experience or equivalent experience in a regulated industry
Experience with SmartCAPA, Oracle and Crystal Reports
Experience handling deviations, investigations and CAPAs
Experience in medical devices
Skills
Spreadsheets
Word processing
Database software
SmartCAPA
Oracle
Crystal Reports
21 CFR 820
ISO 13485
ISO 14791
Statistical methodologies
Quality control tools
Lean manufacturing
Six Sigma
Benefits
Health insurance
Dental
401(k)
Health savings account
Paid vacation
Paid sick leave
Paid holidays
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
Provides complex quality engineering work for specific product lines under broad supervision and guidelines. Basic responsibilities include: failure investigation, oversight/determination of disposition of nonconforming materials, conducting and updating risk analysis documentation and processes, defining/refining quality inspection plans, performing data collection and trending for presentation of key metrics, identifying and addressing supplier quality issues, reviewing and generating validation/protocol data, and optimizing and improving quality systems and documentation.
ESSENTIAL FUNCTIONS PERFORMED
1.
Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
2.
Investigates a moderate number of engineering variables in completing assignments that have clear and defined objectives.
3.
Works independently on standard projects while assistance is furnished on unusual problems.
4.
Responsible for risk management documentation for assigned product line(s) or processes; identifies and updates failure modes and related process/product improvements by facilitating teams and implementing required changes.
5.
Reviews, approves and generates Engineering Change Notifications (ECNs) to update or generate: verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s).
6.
Evaluates and participates in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required.
7.
Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
8.
Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
9.
Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of: quality policy, quality objectives, audit results, analysis of data, etc.
10.
Evaluates the work environment in which product is manufactured, and ensures it is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
11.
May participate in design and development activities.
12.
Performs other related duties and tasks as required.
Requirements
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting – Not to exceed 50 lbs. – local practice may apply.
• 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/or experience equivalent to a Bachelor’s Degree in Chemistry or related field with five years quality engineering experience
• Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member.
• Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.
• Proven ability to work effectively in a team environment through conflict resolution and negotiations.
• Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc.
• Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
Nice to have
PREFERRED QUALIFICATIONS
• Medical device experience or equivalent experience in a regulated industry.
• Experience with SmartCAPA, Oracle and Crystal Reports.
• Experience handling deviations, investigations and CAPAs.
• Experience in medical devices
COMPETENCIES
• Engineering techniques/evaluation/selection/application
• Engineering variable analysis
• Plans/surveys/structures/equipment
• Supervisory assistance
• Special projects/ECN’s/prototype creation
• NC causes/corrective actions/dispositions
COMMENTS
Infectious Control Risk Category II:
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 II states employment and procedures that may 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.
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