Quality Engineer Job Listing at Kelly Services in Irvine, CA (Job ID US3596349_BH9879111)

Description

Quality Engineer 
The Staff Quality Engineer – Leads, plans, supervises, and coordinates 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 develop other engineers. A few of the responsibilities may involve leading a team of Quality Engineers and 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.

• 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 with quality improvement opportunities as appropriate to legacy products,?continuous improvement and customer satisfaction. 
• Oversight, from a Quality NPD perspective, of 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, 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.). Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria. 
• Support sterility, biocompatibility and packaging test requirements following company standard operation procedures for new products. 
• 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. 
• Recommend issue resolution to management for significant capability and compliance?issues. 
• Works closely with functional leadership in planning and executing project milestones. 
• Plans, develops, coordinates, and directs one or more large important engineering projects or a?number of small projects with many complex features. 
• Carries out complex or novel assignments requiring the development of new or improved?techniques or procedures. 
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or?equipment when necessary, data are insufficient or confirmation by testing is advisable.
• Bachelor's degree, required; preferably in engineering and/or scientific discipline 
• Master's degree is preferred 
• A minimum of 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry

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® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

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.

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