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:** Quality **Job Sub** **Function:** Supplier Quality **Job Category:** People Leader **All Job Posting Locations:** San Jose, 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 **We are searching for the best talent for a Manager Supplier Quality Engineer to be located at San Jose, CA.** The Manager Supplier Quality Engineer is responsible for the quality aspects of RAD Monarch suppliers and/or external manufacturers. This includes responsibility for developing, implementing, and maintaining company Purchasing Control processes and procedures for internally utilized suppliers and/or external manufacturing operations. Leads mitigation of key supply chain issues/risks (supplier related) to improve and increase supplier reliability & performance. Leads supplier selection and supplier qualifications activities, ensuring suppliers/external operations meet RAD Monarch quality and regulatory requirements. Executes within & improves the Purchasing Controls/Quality Management System. Responsible for managing supplier related systems which include but not limited to change control, NC/CAPA, Quality Agreements, specification development. Provides guidance and support to project teams and affiliates regarding outsourced activities. Influencing business partners/project teams to continuously comply with purchasing procedures. Partners with other members of the supply chain organization to promote new product introductions and ensure continuity between R&D and commercial supplier and/or external manufacturing projects. Adheres to environment policy, procedures, and supports department environmental objectives. **Key Responsibilities:** + Manages performance and partners with supplier and/or external manufacturers to address challenges and execute improvement plans. + Tracks and trends key quality indicators/metrics to monitor supplier and QMS performance. + Responsible for quality technical assessments, quality agreements, supplier change control, supplier non-conformance, and CAPA related activities. + Recruits, coaches, and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. + Partners with internal customers (Sourcing, Planning, QA, Operations, R&D, Regulatory, Distribution, Marketing, etc.) and suppliers and/or external manufacturers to ensure compliance to product requirements, material/component specifications, company procedures, FDA, ISO, etc. + Conducts supplier qualification activities at existing and prospective supplier and/or external manufacturers as needed. + Defines quality requirements for supplier and/or external manufacturing activities (i.e., material, products, equipment, services, sterilization, etc.). + Lead/support internal and/or external regulatory inspection related activities. + Accountable, as applicable for compliance in accordance with regulations such as and from, but not limited to, FDA QSR, ISO 13485, EU MD Directive/Regulations, FDA 21 CFR 820, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA for the company’s products including medical devices. + Lead/support decisions that are aligned with management objectives regarding work processes, plans, and schedules to achieve department objectives. + Responsible for communicating business related issues or opportunities to next management level. + Tracks and report progress across projects and department commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans and responsible for communicating business related issues or opportunities to next management level. + Performs other duties as assigned by management. **Qualifications** **Education:** + A minimum of a Bachelor’s Degree is required. A focus degree in Engineering or related science/technical field or an equivalent is preferred. **Experience / Skills** **Required:** + Minimum of 6 years of relevant experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation. + Minimum 5 years in a supplier quality related role. + Current or former (technical/engineering) people management + Proven track record on continuous improvement initiatives and improvement methodologies. + Prior manufacturing, plant, or technical background. + Demonstrated knowledge of manufacturing principles and practices, and procedures. + Broad experience with quality systems, including but not limited to validation, nonconformance, CAPA systems and investigations, laboratory controls, production and process controls. + Experience with documentation and technical writing skills, in a regulated compliance environment. + Through understanding of 21 CFR 820, ISO 13485, and ISO 14971 requirements. + Demonstrated ability to identify compliance risks and assess business impact. + Ability to deal with complex issues using deductive reason, critical analysis skills and systematic approaches. **Preferred:** + Proven track record in leading international teams or projects and influencing across borders. + Green Belt or higher rank and/or Certified Lead Auditor (ISO 13485) + Direct experience in plan and/or supplier GMP audits + Component Qualification/Process Validation experience + New production introduction experience. + Prior experience with FDA inspections + Broad knowledge of Quality System Regulations and Supplier Quality Management principles **Other:** + This position may require up to a 20% of domestic and/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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. **The anticipated base pay range for this position is :** $114,000 to $197,800 Additional Description for Pay Transparency: 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)). This position is eligible to participate in the Company’s long-term incentive program. 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits