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:** Warsaw, Indiana, United States of America **Job Description:** Johnson & Johnson MedTech Orthopedics (a member of the Johnson & Johnson Family of Companies) is currently seeking a **Quality Engineer II** to join our outstanding team located in **Warsaw, Indiana.** **About MedTech** 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 The Quality Engineer II position will apply leadership, interdependent partnering, and Quality Engineering expertise to ensure efficient and effective quality & compliance and continuous improvement in our end-to-end business with a focus in manufacturing operations. They will also apply these principles and problem-solving skills to develop and optimize products & processes that are aligned with the overall business vision. This individual will support process containment and bounding of nonconforming product. They also apply appropriate risk management to prevent unanticipated failure modes and improve capability of processes. They pioneer methods and techniques to be used or adapt standard methods to meet needs. They coordinate phases of work internally and externally and may direct activities of technical support staff. This role supports new product introduction, continuous improvement initiatives, and base business products and processes. **Key Responsibilities:** + Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, GxP, and other applicable regulatory requirements + Identifying and supporting resolution of Quality Issues. Owns and supports investigation, bounding, actions, reviews, and approval of non-conformances, CAPAs, and audit findings. + Developing, tracking, and reporting quality metrics to improve Quality Systems. + Conduct risk-based decision making and create and update risk documentation and manufacturing control plans. + Use lean principles to make process improvements. + Perform validation activities and support NPI projects as part of design transfer. + Handle conflict resolution as it relates to technical situations. + Coaching others on quality event investigation processes **Qualifications** **Education:** + Bachelor’s or equivalent degree in Engineering is required. **Experience and Skills** **Required:** + 2 years of experience in a GMP and/or ISO regulated industry and experience with FDA regulated environment. + Supporting a production environment. + Process Validation expertise. **Preferred:** + Strong knowledge of statistical software packages and the ability to facilitate decision making practically, graphically, and analytically. + Project management/leadership experience or certification. + Training or certification in Lean or Six Sigma Methodologies. + Technical understanding of manufacturing and inspection equipment and processes. + Strong organizational skills. + Critical thinking and attention to detail. + Excellent verbal communication and technical writing. + Ability to analyze and present data that facilitates & drives decision making. + Perform "hands on" problem solving. **Other:** + Ability to communicate proficiently in English, both verbally and in writing. + This position may require up to 10% domestic or international travel. 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.