Quality Engineer II, Medical Devices

Medtronic plc; Irvine (CA); On-site; USD 79,000 - 119,000; Full time

Job summary

Medtronic plc in Irvine, California, is seeking a Quality Engineer II to join our Global Operations and Supply Chain Quality Operations team. You will support programs within our Quality Management System and drive day‑to‑day quality and compliance in the development and manufacturing of medical devices.

The role emphasizes collaboration with engineering and manufacturing, applying statistical methods, and ensuring documentation compliance while growing professionally in a hands‑on, onsite

Qualifications

• 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.
• Preferred degrees include Mechanical, Industrial, Biomedical Engineering or related field.
• Experience with NCMRs, CAPAs etc.

Responsibilities

• 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 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 design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Skills

Analytical skills

Quality engineering principles

Cross-functional collaboration

Prioritization

Education

Bachelor’s degree

Master’s degree

Tools

ANOVA

Capability Analysis

DOE

Job description

Medtronic plc in Irvine, California, is seeking a Quality Engineer II to join our Global Operations and Supply Chain Quality Operations team. You will support programs within our Quality Management System and drive day‑to‑day quality and compliance in the development and manufacturing of medical devices.

The role emphasizes collaboration with engineering and manufacturing, applying statistical methods, and ensuring documentation compliance while growing professionally in a hands‑on, onsite