**_Kelly Science, Engineering, Technology, and Telecom_** _, a managed solution provider and business unit of_ **_Kelly Services_** _, is seeking_ **_Quality Engineers_** _for a long-term_ **_Hybrid_** _contract with one of our global medical device clients in_ **_Irvine, CA._** _Our Client is a global leader in the science of diagnosing and treating heart rhythm disorders. Established their leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter._ **_Join a Leading Innovator in Cardiac Care and Device Development_** _The_ **_Quality Engineers_** _will be supporting the transfer between NPD and Manufacturing._ **_Hybrid_** _2 days on-site one week, 3 days on-site the next…there will be times when they need to be on site 5 days when there is testing._ _The_ **_Quality Engineer_** _– Working with other functional groups, including_ **_R&D and Operations_** _in support of_ **_new product development_** _,_ **_engineering projects_** _,_ **_quality assurance activities_** _, and_ _plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed_ **_throughout lifecycle of product_** _. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will be considered a subject matter expert (SME) on Quality matters, relevant Quality tools and will work on complex problems and projects. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. Shares technical expertise with others and develops other engineers. A few of the responsibilities may involve collaborating with other members of the Design Team. Will contribute to activities including risk management document development, creation, and design of catheter test methods, authoring of test protocols, and testing of products during their development cycle._ **_REQUIRED_** **_KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES_** + _Bachelor’s degree, required; preferably in engineering or scientific discipline_ + _4-5 years of quality engineering experience._ + _Catheter experience or class 3 delivery preferred_ + _Experience in design transfer – DBT (testing of finished devices)_ + _Process / equipment investigations_ + _CAPA experience a plus_ + _Manufacturing, or research and development experience medical devices_ + _Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations_ + _Ability to develop and implement Quality standards_ + _Demonstrated auditing and problem-solving skills_ + _Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies_ + _Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization._ + _Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA is a plus._ + _Working knowledge of SolidWorks, other CAD-based programs (ie. basic dimensioning, tolerance stack analysis) is a plus._ + _Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools is a plus._ + _Lean manufacturing experience_ + _Knowledge of Quality and operations systems and processes, including GMP_ + _Working knowledge of CAD software (Solidworks, AutoCAD) Working knowledge of SolidWorks, other CAD based programs (i.e.. basic dimensioning, tolerance stack analysis) is a plus._ + _Experience with Minitab, R and other statistical software is a plus._ + _Geometrical Dimensioning and Tolerancing (GD&T) experience with an understanding of ASME Y14.5._ _Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsors_ 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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. 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.