Senior Design Assurance Quality Engineer I- South Jordan, UT
Merit Medical Systems, Inc. | |
paid holidays, 401(k) | |
United States, Utah, South Jordan | |
1600 W Merit Pkwy (Show on map) | |
Sep 22, 2024 | |
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 extensive and diversified design assurance/quality engineering support for products and processes while completing projects in broad areas of assignment supporting research and development (R&D). Fulfills requirements associated with product development, design controls, product risk management, and usability engineering. Ensures that Merit products are designed, tested, and manufactured in compliance with all applicable agency/internal quality requirements and optimizing quality systems and documentation.ESSENTIAL FUNCTIONS PERFORMED ****This position sits in South Jordan, UT. We will relocate a qualified candidate 1. Participates in design and development activities assuring the design requirements are meet with quality engineering approaches. Guides the R&D design team as subject matter expert of Design Control through Design Inputs, Design Verification, Design Outputs, Design Validation, Usability/Human Factors, and Process Validation. 2. 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. 3. 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). 4. Conducts complete and conceptually related studies to approach technical problems, where the problems are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques. 5. 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. 6. Contributes techniques which are of material significance to solve specific problems and drive continuous improvement. 7. 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. 8. May plan, organize, mentor, and supervise the work of engineers or technicians on various engineering projects and quality system compliance issues. 9. Mentors and evaluates competency of Quality Auditors, Design Assurance/Quality Engineers, and technicians, by providing training or other actions required to satisfy quality objectives. 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. Supports Internal Audit and supplier audit activities, performing audits, writing audit reports, and following up on effectiveness of corrective/preventative actions. 15. Performs other related duties and tasks as required. ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
SUMMARY OF MINIMUM QUALIFICATIONS
PREFERRED QUALIFICATIONS
COMPETENCIES
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 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 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. |