Merit Medical Systems, Inc. South Jordan , UT 84095
Posted 1 week ago
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
Develops, interprets, and implements Supplier Quality policies and procedures. Facilitates compliance globally, including monitoring and measuring the performance of suppliers. Responsible for Global Supplier management; qualification, classification, performance, monitoring, nonconformance (NCMR), corrective and preventive action (SCARs), change control (ECNs, SCNs), and component classification / qualification activities. Works in close collaboration and partners with other divisions, departments, and functions, to optimize overall operational efficiency and effectiveness while maintaining & developing best in class quality systems.
ESSENTIAL FUNCTIONS PERFORMED
1.Leads the Global Supplier Quality team by providing expert-level Quality functional leadership, guidance, and direction to the Supplier Quality team on the Quality Body-of-Knowledge for supplier controls related to components and materials used in medical devices, drug/device combination products, and purchased finished goods.
2.Identifies and leads improvement opportunities to proactively ensure internal and vendor compliance to all applicable internal, domestic, and international quality regulations, including but not limited to US 21 CFR 820, ISO 13485, ISO 14971, EU MDR, etc.
3.Leads Supplier Quality engineering efforts to partner with our vendors to reduce risk, improve processes, and reduce waste using the quality improvement tools of process control & monitoring, DOE, risk analysis, problem solving processes, protocol development, reporting, trend analysis and reaction, capability analysis and measurement system analysis.
4.Partners with the Operations, Sourcing and Supply Chain organizations to define and implement effective Supplier Change Management and Supplier Development practices.
5.Develops and maintains effective Quality Metric performance and identifies and executes activities to enhance purchased product quality, reduce supplied material variances, and resolve decreases in Supplier performance.
6.Leads and ensures appropriate execution of the supplier and product qualification processes (e.g., supplier audit program, PPAPs, etc.) including maintaining a robust Supplier Quality management process.
7.Ensures engagement in strategic sourcing initiatives in partnership with business stakeholders to assure that Supplier Quality is evaluated as a critical component within sourcing processes.
8.Supports product manufacturing activities, as necessary.
9.Performs other related duties and tasks 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 Degree in engineering or related science
A minimum of seven (7) years in Medical Device, Pharmaceutical, or Combination Product experience in Quality or Supply Chain functions in a private, public, government or military environment.
At least five (5) years of work-related experience in quality management, demonstrating team leadership, compliance excellence, value improvement, and risk reduction.
PREFERRED QUALIFICATIONS
COMPETENCIES
a) Problem solving
a) Budget management
b) Work/Project management
a) Quality control principles - inspection / sampling plans
b) Non-Conformance process
a) Staff training/development
a) Supervisory process
COMMENTS
Infectious Control Risk Category III:
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.
Merit Medical Systems, Inc.