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Senior Design Quality Engineer

2 months ago

South Jordan, United States Merit Medical Full time

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 Accountable for product maintenance through the application of Quality Engineering skills for medical devices. Handle projects and tasks related to product acquisitions and sustaining product maintenance and play an active role in the processes to ensure products meet quality standards consistent with both corporate policies, while meeting all design control and other regulatory requirements.

ESSENTIAL FUNCTIONS PERFORMED

1. Provide guidance and Quality oversight to ensure establishment and execution of robust design control programs aligned with regulatory requirements and industry standards. 2. Support new product development and existing product sustaining activities to ensure work follows proper design control. 3. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development teams and identifying Quality needs, product improvements and customer requirements. 4. Ensures adequate design control documentation and records are maintained to support life cycle of design history. 5. Support new product development execution of design control and ensure tasks are completed adequately to include project planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and design history files and other activities as needed. 6. Provide guidance and training to cross-functional associates to help increase knowledge of regulations and standards for Devices and Combination Products. 7. Responsible to evaluate design verification results and data utilizing statistical analysis to ensure design delivers an acceptable quality level during manufacturing with properly established product specifications. 8. Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk. 9. Review and authorize Quality approval for new product and/or device design specifications including product performance specifications, test methods, acceptance criteria, and release. 10. Review and assess work performed by R&D and other business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues. 11. Work with Validation team providing Quality Engineering support for Acquisitions, Product and/or Device transfer, Scale-Up, and Process Validation. 12. Lead or participate in ISO 14971 Risk Management activities appropriate to the initiative or situation. 13. Monitor quality data from Product Complaints process, Manufacturing reports, Service reports and customer input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Field Assurance, Manufacturing, Engineering, and Regulatory. 14. Initiate Corrective and Preventative Action plans and perform efficacy follow up. 15. Conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet BD and regulatory requirements. 16. Participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPs and established Quality Systems. 17. Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries. 18. Support regulatory inspections as needed. 19. Lead investigation and Field activities relating to Field Corrective Actions, when needed. 20. Performs a variety of other tasks and related work, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting -- Not to exceed 50 lbs. -- local practice may apply. • Writing • Sitting • Standing • Bending • Visual acuity • Color perception • Depth perception • Reading • Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor's of Science in STEM or a related field required. • Experience with 6+ years in medical device industry Engineering. Design controls, risk management and change controls experience is required.

PREFERRED QUALIFICATIONS

• American Society of Quality (ASQ) certification (CQE, CQA, etc).

COMPETENCIES

• Engineering problem solving / root cause investigation • Engineering research • Inventions/new designs/techniques • Project management skills

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. #J-18808-Ljbffr