Description
Kelly Science, Engineering, Technology, and Telecom, a managed solution provider and business unit of Kelly Services, is seeking Quality Engineers for a long-term 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
Medical Device Quality Engineers
The Quality Engineer will be working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
Key Responsibilities:
• Utilizing Quality Engineering tools/processes in the 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 the Non-Conformance Report (NCR) process for 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, and 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 is 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
• Maintaining blank time records with necessary information on all contracts for business partners to use.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES
• Bachelor's degree, required; preferably in engineering and/or scientific
• 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
• 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 is a plus.
• 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.
• Experience with Minitab, R and other statistical software is a plus.
• Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools is a plus.
• Lean manufacturing experience is a plus.
• Knowledge of Quality and operations systems and processes, including GMP is a plus.
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 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 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. 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.
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