Quality Engineer

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

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.)

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Find what's next with Kelly.

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About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.

Kelly Services is proud to be an Equal Employment Opportunity and affirming vendor. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and affirming vendor. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.