At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Quality Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** US321 CA Redwood City - 150 Shoreline Dr, US328 CA Santa Clara - 5490 Great America Pkwy **Job Description:** We are searching for the best talent for a Staff Quality Engineer to be in Santa Clara, California. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech. Our team advances the MONARCH™ surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products. We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes and advance medical professionals’ skills. **You will be responsible for:** + Support product requirements, risk management, verification strategies, validation strategies, and quality audits. + Collaborate on, review, and approve design, manufacturing, quality, engineering, and validation / qualification documentation. + Collaborate cross-functionally with, including but not limited to, Quality, R&D, Supply Chain (including Manufacturing), Regulatory Affairs, Marketing, Clinical Affairs/Research. + Develop, revise, and apply quality system procedures. + Drive prevention and detection of defects at earliest phase of product design, continuous improvement, and customer satisfaction. + Investigate and resolve product and quality system nonconformance's. + Provide recommendations on statistical analysis and analytical problem solving for product development. + Lead and execute design and quality projects. + Ensure compliance with GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and other applicable standards and regulations. + Guide junior personnel in achieving their responsibilities. **Qualifications/Requirements:** + Bachelor’s degree or equivalent in engineering or relevant science field, and 5+ years of related experience; or master’s degree or equivalent in engineering or relevant science field and 3+ years of related experience + Experience in medical device industry or other highly regulated industry + Experience with electrical-mechanical systems + Experience with standards and regulations such as ISO 13485, ISO 14971, IEC 60601, IEC 62304, 21 CFR 820 + Experience in design and development, risk management, statistics, product inspection, technical writing + Experience in working within and across teams + Effective communication skills with different levels of management and organizations + Ability to work in a fast-paced environment, managing multiple priorities + Ability to work with minimal supervision + Project leadership experience + Must be willing work in-person at Santa Clara, California, USA office location + Ability to travel up to 10% domestic and international + Proficiency in use of data visualization software, e.g., Power BI, Tableau + ASQ Certified Quality Engineer certification + ASQ Certified Reliability Engineer certification + Green Belt certification in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.