Quality Engineer – Cardiac Catheters & Devices (Irvine)

Kelly Services; Irvine (CA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

Vacation

Sick Time

Holiday Pay

Job summary

Johnson & Johnson, Irvine, CA, is hiring a Quality Engineer to support production demand and new product development in the field of cardiac electrophysiology devices. The role emphasizes process validation, risk management, and design controls to ensure compliant, high-quality medical products.

The position collaborates with R&D and Operations, applying Six Sigma and SPC methods, and involves NCR handling, process transfer, and cross-functional teamwork. Competitive benefits apply.

Responsibilities

• Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Leading efforts for continuous quality and customer satisfaction improvement opportunities.
• Support Non-Conformance Report (NCR) process for Client facilities located in the U.S.
• Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.).
• Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is properly transferred to manufacturing per applicable specifications.
• Technical problem solving, failure analysis, and root cause determination.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
• Assigns/reviews quality inspection testing and test data. Keeps department supervisor abreast of activities and issues of the quality group.
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed (e.g., review of work orders, support cleanroom activities, etc.)

Job description

Johnson & Johnson, Irvine, CA, is hiring a Quality Engineer to support production demand and new product development in the field of cardiac electrophysiology devices. The role emphasizes process validation, risk management, and design controls to ensure compliant, high-quality medical products.

The position collaborates with R&D and Operations, applying Six Sigma and SPC methods, and involves NCR handling, process transfer, and cross-functional teamwork. Competitive benefits apply.