Senior Quality Engineer

Medtronic•Santa Ana, CA

11d•$98,400 - $147,600•Onsite

About The Position

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Medtronic Santa Ana is looking for an experienced quality engineer to support our manufacturing in Santa Ana, CA. This position is located in Santa Ana, CA (100% on-site role) and reports into Global Manufacturing and Supply Chain Quality organization. Santa Ana site is part of the OC Campus, consisting of Santa Ana, CA (primarily Cardiac Surgery, Structural Heart portfolio) and Irvine, CA (primarily Neurovascular portfolio). The primary responsibilities for this role includes project management, NPI and day-to-day productions supports with close collaboration with cross-functional supporting teams (engineering, productions, OPEX, microbiology, PMO, facilities, etc.).

Requirements

Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality. OR PhD with 0 years relevant experience.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).

Nice To Haves

Lean Six Sigma certification
First Time Quality experience
Animal tissue processing experience
ASQ certification such as CQE, CQA

Responsibilities

Managing and leading NCMRs, CAPAs, and other quality activities that arise.
Managing and/or supporting projects (sustaining projects and NPI projects).
Executing Test Method Validations.
Supporting process validation activities (DQ/IQ/OQ/PQ).
Leading and/or providing guidance for problem solving using DMAIC methodologies.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.