Senior Quality Assurance Engineer I

Merit-Medical-Systems-Inc.; South Jordan (UT); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical/dental insurance

401(k)

Onsite clinic

Paid holidays

3 weeks vacation

Job summary

Merit Medical is seeking a Quality Engineer to perform both routine and advanced quality engineering tasks for specific product lines. The role involves risk analysis, validation/verification support, and driving quality improvements across processes and documentation.

You will mentor team members, review ECNs, and participate in supplier audits while ensuring compliance with 21 CFR 820 and ISO standards. This position requires collaboration across cross-functional teams in a manufacturing

Qualifications

• Bachelor's degree in Engineering or related field; six years of quality engineering experience.
• Strong interpersonal and communication skills; ability to work in a team.
• Solid knowledge of 21 CFR 820, ISO 13485, ISO 14791, and other medical device standards.
• Experience with statistical methodologies and quality tools (lean, Six Sigma).
• Familiarity with regulatory requirements and quality system improvements.
• Experience with quality audits, CAPAs, deviations, and supplier quality activities.

Responsibilities

• Perform routine and complex quality engineering for product lines under supervision.
• Lead risk management activities and update risk analyses.
• Review and approve ECNs for validation, verification, and inspection methods.
• Mentor engineers and technicians; supervise as needed.
• Perform supplier quality audits and monitor supplier performance.
• Investigate nonconformances and drive corrective and preventive actions.
• Ensure quality system effectiveness through data analysis and process improvements.
• Support internal and supplier audits and maintain documentation.

Skills

Quality engineering

Data analysis

Team collaboration

Written and verbal communication

Education

Bachelor's degree in Engineering or related field

Tools

MasterControl

SmartCAPA

Oracle

Crystal

Excel

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 SHIFTDAY (United States of America)SUMMARY OF DUTIESProvides routine and complex quality engineering work for specific product lines under broad supervision and guidelines. 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 PERFORMED1. Conducts complete and conceptually related studies to approach technical problems, whereas the problems are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques.2. Performs technical work where available guides and precedents contain critical gaps, are only partially related to the problem, or may be largely lacking due to the novel character of the project.3. Contributes techniques which are of material significance to solve specific problems and drive continuous improvement.4. Keeps abreast of new scientific methods, standards, regulations, and developments affecting the organization for the purpose of recommending changes to processes, systems or designs warranted by such developments.5. May plan, organize, mentor, and supervise the work of engineers or technicians on various engineering projects and quality system compliance issues.6. Responsible for coordinating risk analysis/management activities. This may include leading risk management analysis meetings, documenting results, following up to ensure risk mitigation and facilitating improvements.7. 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).8. Mentors and evaluates competency of Quality Auditors, Quality Engineers, and technicians, by providing training or other actions required to satisfy quality objectives.9. 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.10. Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.11. Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.12. 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, risk management, etc.13. Evaluates the work environment in which product is manufactured, and ensures it is adequately controlled and monitored, with sufficient personnel and safety production controls.14. May participate in design and development activities.15. May support Internal Audit and supplier audit activities, performing audits, writing audit reports, and following up on effectiveness of corrective/preventative actions.16. Performs other related duties and tasks as required.ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDSLifting - Not to exceed 50 lbs. – local practice may apply.WritingSittingStandingBendingVisionColor perceptionDepth perceptionReadingField of vision/peripheralFine motor skillsNoiseChemical vaporsMINIMUM QUALIFICATIONSEducation and/or experience equivalent to a Bachelor's Degree in Engineering or related field with six years of quality engineering experience (to include experience in the development and implementation of effective quality systems).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.Knowledge of applicable regulatory agency regulations.Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.PREFERRED QUALIFICATIONSMedical device experience or equivalent experience in a regulated industry.Experience handling deviations, investigations and CAPAs.Experience with MasterControl, SmartCAPA, Oracle and Crystal.COMPETENCIESEngineering problem solving/decision makingTechnician supervisionSpecial projects/ECN's/prototype creationNC causes/corrective actions/dispositionsCOMMENTSInfectious 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 NightsMedical/Dental & Other Insurances (eligible the first of month after 30 days)Low Cost Onsite Medical ClinicTwo (2) Onsite CafeteriasEmployee Garden | Gardening Classes3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays401K | 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.