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:** Irvine, California, United States of America **Job Description:** **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 \#Li-Hybrid An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for **Quality Engineer 1 NPD** to be in **Irvine, California** . The NPD Quality Engineer 1 executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of a product. Involved in 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 in developing quality-engineered systems and products, and support qualification and validation activities. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. A few of the responsibilities may involve 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. If you are an individual who enjoys working with the other team members and changing the lives of our patients around the world, come join our team! **SECTION 1: JOB SUMMARY** Under general supervision, participate in new and sustaining product/process teams to support design verification tests, process validations, quality processes. 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 work on complex problems and projects. Will show leadership by innovating compliant approaches and solutions to problems. Will receive technical guidance on sophisticated problems, but independently develops approaches and solutions. Work is usually well defined and is checked for progress and reviewed for accuracy upon completion. Carries out calculations and documents test results. Writes and/or reviews technical reports, develops charts, graphs, schematics and drawings to illustrate improvement processes. Ensures tools and test equipment are properly calibrated and repaired. Makes recommendations on improving quality, efficiency, cost of company product(s), processes, and/or efficiency techniques. Ensures all documentation is recorded properly and follows procedures. **SECTION 2: DUTIES & RESPONSIBILITIES** In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: + 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 for continuous quality and customer satisfaction improvement opportunities. + Support Non-Conformance Report (NCR) process for BWI 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.). + 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. + 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. Additional Duties: o Responsible for communicating business related issues or opportunities to next management level o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. o For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed **SECTION 3: EXPERIENCE AND EDUCATION** + Bachelor’s degree, required; preferably in engineering and/or scientific discipline + 0- 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry **SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS** + 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. **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 \#Li-Hybrid We are searching for the best talent for **Quality Engineer 1 NPD** to be in **Irvine, California** . The NPD Quality Engineer 1 executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of a product. Involved in 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 in developing quality-engineered systems and products, and support qualification and validation activities. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. A few of the responsibilities may involve 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. If you are an individual who enjoys working with the other team members and changing the lives of our patients around the world, come join our team! **Key Responsibilities:** + Provide support in quality improvement opportunities as appropriate to new products, continuous improvement and customer satisfaction. + Understand the investigation processes related to corrective and preventive action (CAPA) as well as nonconformances (NC), identification of root cause and recommend action(s). Generate nonconformance reports and assist in investigation, final disposition and corrective action. + Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). + Assign/review quality inspection testing and test data. Communicate activities and issues to supervisor. + Reviews documents for GDP. + Support audits. + Help execute and develop process and product validation/verification protocols and reports, equipment qualifications and engineering change orders. **Qualifications** **Education:** + A minimum of a Bachelor’s degree with focus in engineering and/or scientific field is preferred. Alternatively, 2+ years of quality, manufacturing, or research and development experience in a medical device or other regulated industry. **Experience and Skills:** **Required:** + Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations + Ability to effectively collaborate and connect with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes + Ability to function in a team environment and deliver on team objectives + Strong attention to detail **Preferred:** + Familiarity with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices. + Developed presentation skills. + Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA. + Working knowledge of SolidWorks, other CAD based programs (i.e., basic dimensioning, tolerance stack analysis). + Experience with Minitab, R and other statistical software. + Six Sigma or lean manufacturing experience, and/or knowledge of Process Excellence tools. + Experience in Class III medical devices and/or cardiac products **Other:** + This position may require up to 20% of domestic and/or international travel. **Additional Information:** **The expected base pay range for this position is $59000 - $85000 annually** + The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. + This position is overtime eligible + Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. + Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). + This position is eligible to participate in the Company’s long-term incentive program. + Employees are eligible for the following time off benefits: o Vacation –120 hours per calendar year o Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year o Holiday pay, including Floating Holidays –13 days per calendar year o Work, Personal and Family Time - up to 40 hours per calendar year o Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child o Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member o Caregiver Leave – 10 days o Volunteer Leave – 4 days o Military Spouse Time-Off – 80 hours + Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on October 1, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications 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 **The anticipated base pay range for this position is :** 59000 - 85000 Additional Description for Pay Transparency: