Quality Engineer II- Manufacturing Operations
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
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.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.
Please note that this is a fully onsite role based in Irvine, California.
Responsibilities may include the following. Additional duties may be assigned as needed.
Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
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.
Design or specify inspection and testing methods and equipment, conduct quality assurance testing, and perform statistical analyses to evaluate product or material nonconformance and support resolution.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Contribute expertise in areas such as design quality, incoming materials, production control, product evaluation and reliability, inventory control, and research and development as they relate to product or process quality.
Must Have: Minimum Requirements
Requires a Baccalaureate degree and minimum of 2 years of relevant Quality experience OR Master's degree with a minimum of 0 years relevant experience.
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.
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