Quality Engineer

Kelly Services, the leader in Manufacturing Career Placement is proud to announce we are now partnering with Johnson & Johnson located in Irvine, CA. Johnson & Johnson is rapidly expanding and is immediately hiring a qualified Quality Engineer support production demand and new product development.

Position Summary:

As an Quality Engineer you will play a key role in developing and assembling innovative electrophysiology (EP) catheters and medical devices used in the diagnosis and treatment of heart rhythm disorders.

Johnson & Johnson is a global leader in cardiac electrophysiology, providing advanced catheter technology that helps physicians accurately map and treat arrhythmias, including atrial fibrillation.

Job Title: Quality Engineer
Benefits: Medical, Dental, Vision, 401K, Vacation, Sick Time, and Holiday Pay
Location: Irvine, CA

Job Responsibilities/ Requirements:
Kelly Services, the leader in Manufacturing Career Placement is proud to announce we are now partnering with Johnson & Johnson located in Irvine, CA. Johnson & Johnson is rapidly expanding and is immediately hiring a qualified R&D Technician to support production demand and new product development.

Position Summary:

Johnson & Johnson is a global leader in cardiac electrophysiology, providing advanced catheter technology that helps physicians accurately map and treat arrhythmias, including atrial fibrillation.

Benefits: Medical, Dental, Vision, 401K, Vacation, Sick Time, and Holiday Pay
Location: Irvine, CA

Job Responsibilities/ Requirements:

• 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 practicesfor 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.)

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