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Associate Quality Engineer, New Product Development

Company: Johnson & Johnson
Location: Santa Clara
Posted on: February 24, 2021

Job Description:

Job DescriptionRobotics & Digital Solutions, part of Johnson & Johnson of companies, is recruiting for an Associate Quality Engineer, New Product Development, located in Santa Clara, CA!Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.The Associate Quality Engineer, New Product Development will be responsible for providing quality engineering support for New Product Development.Responsibilities* Support launch and stabilize new product launches through concept, design, development, and steady-state processes.* With support from more experienced QE, drives the development of product requirements, verification strategies, and validation strategies.* Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards* Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.* Proactively engage partners to drive consensus and resolve issues in a timely fashion.* Provide statistical support and analytical problem solving for product development and manufacturing.* Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures.* Develop inspection and sampling plans, test methods, and transfer functions for products and components* Provide support in developing and executing a reliability strategy during new product development.* Participates in risk management process including User, Design and Process FMEA's.* Conducts projects and assignments with technical responsibility based on mentorship from more senior QE.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.RequiredQualifications* Bachelor's Degree in Engineering from an accredited engineering school or related science field. * Previous co-op, internship or work experience and demonstrated leadership/participation in campus programs and/or community service activities.* Excellent interpersonal, organizational, and verbal and written communication skills.* Ability to travel up to 25% domestic and international. * Ability to work at the Santa Clara, CA site Preferred* Advanced Degree * New product development experience * Data analysis especially in Minitab including but not limited to: Hypothesis testing, DOE analysis, Linear Regressions, and Process Capability. * Knowledge of 21 CFR 830 and ISO 13485* Knowledge of Risk Management tools like FMEA's * Comfortable working in a matrix environment and ability to connect with different functional groups and people who work in multiple levels while embracing and driving change.

Keywords: Johnson & Johnson, Santa Clara , Associate Quality Engineer, New Product Development, Engineering , Santa Clara, California

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