Senior Design Quality Engineer
Merit Medical Systems
- South Jordan, UT
- Permanent
- Full-time
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
- 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.
- American Society of Quality (ASQ) certification (CQE, CQA, etc).
- Engineering problem solving / root cause investigation
- Engineering research
- Inventions/new designs/techniques
- Project management skills
- 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