Johnson & Johnson is seeking a Supplier Quality Engineer II to join the organization of Biosense Webster to be located in Irvine, CA. 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/. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong. The Supplier Quality Engineer II (SQE II) provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products. The SQE is responsible for the Quality Management of external suppliers of direct and indirect materials, finished goods and services for the CSS franchise. Also, leads the deployment of the Supplier Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the CSS supply chain. Key Responsibilities: + Lead, develop and implement supplier/purchasing controls and associated activities including Approved Supplier List management, supplier related non-conformances/CAPAs, Supplier Quality Agreements, and Supplier Change Requests + Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management. + Partner with Procurement, R&D, Engineering/Technical Operations, Quality Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions. + Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes. + Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications. + Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Actively participates in discussions to drive resolution. + Prepare Supplier Quality Agreements and drives discussion with supplier while consulting Supplier Quality Manager. + Own and lead the Supplier Quality Relationship Management (SQRM) process for the assigned suppliers. + Perform other duties assigned as needed. **Qualifications** Education: + A minimum of a Bachelor's degree in Engineering, Applied Science or a related technical and quality field is required. Experience and Skills: Required: + A minimum of 2 years of related experience in Operations, Engineering, Quality Engineering or Quality Assurance. Preferred: + Prior manufacturing, plant or technical background + Knowledge of good manufacturing practices in a regulated environment (medical device, pharmaceutical, etc.) + Basic knowledge in plant and/or supplier GMP auditing + Experience with documentation and technical writing skills, in a regulated compliance environment + Basic knowledge of Quality System Regulations is desired + Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches + Knowledge of regulatory compliance requirements (i.e., Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards) + Knowledge of Non-Conformance Reports (NCRs) and Corrective/Preventative Actions (CAPAs) + Process Validation experience + Strong analytical skills, metrics development and ability to identify trends + Knowledge of specific business practices and software applications skills (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project®) Other: + This position may require a 10% of domestic and/or international travel. + Ability to communicate efficiently in English. + Ability to collaborate with all levels of management in cross-functional team environment is required. + Professional Certifications: ASQ CQE, CSQP, CMQ/OE, CSSGB, CSSBB, CQA, and/or Project Management are preferred. The anticipated base pay range for this position is $63,000 to $102,350. 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. 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)). Employees are eligible for the following time off benefits: + Vacation – up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year + Holiday pay, including Floating Holidays – up to 13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on January 22, 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 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.