Quality Engineer II- Manufacturing Operations

Overview

Quality Engineer II position in Medtronic Global Operations and Supply Chain (GOSC) located in Irvine, California. Fully onsite role supporting quality programs within the Quality Management System and day‑to‑day quality and compliance activities in the development and manufacturing of medical devices.

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement 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.
• Ensure 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.

• Baccalaureate degree and minimum 2 years of relevant quality experience, or Master’s degree with minimum 0 years relevant experience.
• Strong analytical skills and solid foundation in quality engineering principles.
• Experience with NCMRs, CAPAs, and related quality processes.
• Experience with process validation, test method validation, and FMEA and risk management.
• Knowledge of statistical tools such as ANOVA, capability analysis, and DOE.
• Strong collaboration skills with cross‑functional teams.
• Experience in medical device manufacturing and familiarity with applicable regulations and standards.
• DRM or Design for Six Sigma certification (preferred).

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related field.

• Baccalaureate degree (outside the U.S. must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A)).
• Two years of relevant quality experience (or equivalent Master’s degree).

The position requires independent mobility, use of a computer, and interaction with peers and co‑workers. Reasonable accommodations may be made for individuals with disabilities.

Medtronic is an equal employment opportunity employer and does not discriminate based on age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Medtronic provides reasonable accommodations for qualified individuals with disabilities.

Applicants must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.