Quality Engineer II
About the role
A Day in the Life
The Medtronic Global Operations and Supply Chain (GOSC) organization is seeking a Quality Engineer II to join our growing Quality Operations team in Irvine, California. In this role, you will support key programs within our Quality Management System and help drive day-to-day quality and compliance activities in the development and manufacturing of innovative medical devices.
We are looking for a collaborative, hands-on professional who is motivated to make an impact in a dynamic environment. The ideal candidate brings strong analytical skills, a solid foundation in quality engineering principles, and the ability to manage multiple priorities effectively while continuing to grow professionally.
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.
Responsibilities may include the following and other duties may be assigned.
- 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.
Must Have: Minimum Requirements
Nice to Have
- Bachelor's degree required in Mechanical Engineering (preferred), Industrial Engineering, Biomedical Engineering, or a related field.
- Knowledge of statistical tools such as ANOVA, Capability Analysis, and DOE.
- Ability to collaborate effectively with cross-functional teams.
- Experience with NCMRs, CAPAs etc.
- DRM or Design for Six Sigma certification.
- Experience with Process Validation.
- Experience with Test Method Validation.
- Experience in medical device manufacturing and familiarity with applicable regulations and standards.
- Experience with FMEA and risk management
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.
Physical Job Requirements
U.S. Work Authorization & Sponsorship
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Medtronic offers a competitive Salary and flexible Benefits Package
Not included in the source posting: about the role.
Who can apply
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