Quality Engineer Job Listing at Kelly Services in Irvine, CA (Job ID US3548457_BH9774539)

Description

Kelly Services the leader in manufacturing career placement is proud to announce, we are now partnering with Johnson & Johnson located Irvine, CA.
We are actively hiring multiple Quality Engineers for long-term hybrid contracts with one of the most recognized global leaders in medical devices.

Position Title: Quality Engineer
Schedule: Monday-Friday 8AM-5PM
Compensation: $45-$55 Hourly 
Benefits: Medical, Dental, Vision, 401K, Vacation, Sick Time, & Holiday Pay
Location: Irvine, CA

Johnson & Johnson is at the forefront of electrophysiology device development, advancing real-time 3D cardiac mapping and navigation technology to improve the diagnosis and treatment of heart rhythm disorders.

As a Quality Engineer, you'll play a key role in transferring New Product Development (NPD) to Manufacturing, ensuring compliance through design verification, process validation, and regulatory alignment. This hybrid role requires a mix of on-site and remote work, with full on-site presence as needed for critical testing.

You'll serve as a subject matter expert (SME), addressing complex quality challenges, leading projects, and driving compliant solutions. Additionally, you'll mentor junior engineers and contribute technical expertise to a collaborative team.

Key Responsibilities:

• Collaborate with R&D and Operations teams to support new product development, engineering projects, quality assurance, and lifecycle management.
• Implement quality engineering tools for the development, transfer, and maintenance of products/processes across the lifecycle.
• Oversee the Non-Conformance Report (NCR) process for U.S. facilities from a Quality NPD perspective.
• Develop and establish quality control measures, supporting risk management plans, including AFMEA, DFMEA, and PFMEA.
• Write, review, and approve validation protocols, reports, equipment qualifications, and engineering change orders.
• Use statistical tools (Six Sigma, SPC, DOE) to analyze data, make acceptance decisions, and improve process capability.
• Ensure that development activities meet design control requirements, applicable standards, and GSPR requirements.
• Conduct technical problem-solving, failure analysis, and root cause determination.
• Lead engineering projects, assess feasibility, and ensure compliance with regulatory requirements.

Required Qualifications:

• Bachelor's degree in Engineering or a related scientific discipline.
• 4-5 years of quality engineering experience.
• Catheter or Class 3 delivery experience preferred.
• Experience with design transfer, including DBT (testing of finished devices).
• Background in process/equipment investigations and CAPA.
• Medical device or regulated industry experience preferred.
• Expertise in Quality Engineering tools, design control, and verification and validation methodologies.
• Ability to analyze data, define problems, and draw conclusions.
• Experience with statistical software (e.g., Minitab, R) is a plus.
• Six Sigma, Design for Six Sigma, and/or Process Excellence experience is preferred.
• Familiarity with CAD software (SolidWorks, AutoCAD) is a plus.
• Lean manufacturing and GMP knowledge is beneficial.

Additional Skills:

• Strong collaboration and communication skills at all organizational levels.
• Practical knowledge of engineering techniques such as DOE, DMAIC, and ANOVA.
• Geometrical Dimensioning and Tolerancing (GD&T) experience, with understanding of ASME Y14.5.
• Ability to make independent engineering decisions and represent the organization in conferences.

Kelly Services, a global leader in workforce solutions, is committed to matching you with top-tier employers. Join a world-renowned company like Johnson & Johnson and take the next step in your career with an exciting and dynamic role.

Please submit an up-to-date resume for immediate consideration.

Thank You
Kelly Services
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. 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. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering/Technology – Project Services?

Looking to work with leading project management organizations at top companies around the world? That's where we come in. At Kelly Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world's most critical challenges. We connect you with opportunities to work on intriguing, innovative, and high-visibility projects—all with a schedule that works for you. Do you prefer the variety and flexibility of short-term projects? Or are looking for a long-term opportunity? Either way, our connections and expertise will help you take your career exactly where you want to go. That's just good planning.

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.

 Apply on company website