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:** Multi-Family Quality **Job Category:** People Leader **All Job Posting Locations:** Anasco, Puerto Rico, United States of America **Job Description:** **About Vision** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. 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** **Site Quality Director to be located in Añasco, PR.** The Site Quality Director leads the Johnson and Johnson Surgery Vision Quality Operations organization, ensuring compliance with quality requirements, continuous supply to customers, compliance and regulatory agencies requirements, among others. Responsible for taking a leadership role in defining short and long-term strategies for the facility. Has accountability through direct reports, over inspection and release of incoming raw materials, in-process and final Quality inspection and testing. Directs the Quality Engineering team and Quality Systems site execution. Engages and collaborates with Franchise Quality teams as well as cross functional Supply Chain functions including Operations, Make Engineering, Production Planning and Logistics and Product management to assure a horizontal approach to resources management and prioritization. **Key Responsibilities:** + Serves as local Quality Systems Management Representative for the site. + Operates tactically within the operations environment to ensure practical and timely provision of Quality decision making. + Oversees management of the day-to-day quality activities. + Makes decisions on non-conforming material, as required by the Quality System procedures. + Evaluates and communicates quality events for elevation to Risk Management Board and/or Quality Board as per applicable procedures. + Develops the site operational Quality strategy as a business partner to Supply Chain Operations and Franchise QA functions to optimize the performance of operations, compliance, and quality systems as well as influence the global integration and alignment of goals across the organization. + Serves as Host for 3rd party audits; participates and presents in Quality and Compliance Executive Reviews, Management Reviews, Quality Boards and others as requested/required. + Reports to Executive Management on the effectiveness of the Quality Management System and any need for improvement. + Ensure the promotion of awareness of applicable regulatory requirements and Quality Management Systems requirements throughout the organization. + Ensures that processes needed for the Quality Management System are documented. + Evaluates the site Quality Operations capabilities, identifies gaps, and recommends issue resolution to Executive Management. Develops and leads innovative initiatives to improve business performance to support visionary changes. + Provides coaching and staff development, manage performance, succession planning, and departmental budget. Is accountable for organizational capabilities to meet current and future business needs. + Serves as a technical expert for functional areas, with conceptual knowledge of all quality functions and business areas. + Serves as Subject Matter Expert (SME) for execution of Quality Systems in the site during inspection readiness activities. Supports the preparation of any communications with FDA related to any follow-ups of inspections carried out at the site. + Directly supports the design and deployment of Quality Systems improvements, standards and policies at site level. + Observes all Company’s Environmental, Safety, and Industrial Hygiene policies and regulations. **Qualifications** **Education:** + Bachelor’s degree in a Life Science, Engineering, Physical Science, or equivalent is required. **Experience and Skills** + A minimum of 10 years of experience in the Medical Devices or Pharmaceutical sector, with 5 years of experience in Quality is required. + Previous people management experience is required. + Regulatory experience, including US Class III (PMA) and US Class II regulations, supporting timely and compliant regulatory submissions, inspections and audits is required. + Demonstrated knowledge of ISO 13485, 21 CFR Part 820, EU MDD/MDR, and MDSAP is required. + Demonstrated knowledge of manufacturing/quality principles and practices is required. + Front-room role experience with FDA (or similar) and Notified Body inspections is required. + Multi-functional experience (Quality, Planning, Operations, Engineering, etc.) is preferred. + Strong verbal and written communication to all levels of the organization, influencing, and leadership skills are required. + Strong project management and problem-solving skills are required. + Ability to influence at senior levels and across functions building strong networks internally and externally. Experience delivering results through influence in a highly matrix environment. + Ability to effectively manage people (both directly and indirectly) and manage projects that include cross-functional teams representing diversified areas is required. + Ability to build strategic partnerships to accomplish company goals in a team environment is required. + Ability to handle multiple projects simultaneously and the judgement to discern and resolve major quality issues is required. + Ability to work in stressful/fast paced environment is required. + Domestic or international travel at 10%, as required. 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. \#LI-Onsite