QA Design Transfer Engineer II

Job Title

QA Design Transfer Engineer II

Company

Merit Medical Systems, Inc.

About 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 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 Performed

• Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
• Works independently on standard projects while assistance is furnished on unusual problems.
• Receives instructions on specific assignment objectives, complex features and possible solutions.
• Responsible for risk management documentation for assigned product line(s) or processes; and identifying and updating failure modes and related process / product improvements by facilitating teams and implementing required changes.
• 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).
• 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.
• Reviews nonconformance records (internal / external) to determine : disposition, root cause and need for corrective and preventive actions.
• Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
• 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.
• Evaluates the work environment, in which product is manufactured, is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
• May participate in design and development activities.
• Performs other related duties and tasks as required.

Essential Physical / Environmental Demands

Summary Of Minimum Qualifications

Preferred Qualifications

Benefits

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing

Referrals & Location

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