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 jnj.com (https://www.jnj.com.) . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. **Job Function:** Quality **Job Sub** **Function:** Quality Assurance **Job Category:** People Leader **All Job Posting Locations:** Ciudad Juarez, Chihuahua, Mexico **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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Mexico - Requisition Number: R-058223 United States - Requisition Number: R-058950 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. We are searching for the best talent for **Site Quality Director** **Purpose:** Develops, implements, and coordinates quality assurance programs and activities such as quality operations, product release, CAPA, non-conformance system and quality laboratories to ensure that released products are safe, effective and of the highest quality and ensures compliance to regulatory requirements and applicable standards. **You will be responsible for** **:** Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: + Might be designated as Management Representative and/or Head of Quality Make for the Site by the Operating Company. + Analyzes, evaluates, and presents information concerning factors such as business situations, production capabilities, manufacturing problems and quality systems indicators. + Oversees the development of policies and procedures which affect operational and compliance + Assures compliance of the Quality System with all regulatory requirements and applicable + Develops initial and subsequent modifications of product assurance programs to delineate areas of responsibility, personnel requirements, and operational procedures within program. + Evaluates contents of reports on product assurance from department heads and confers with top management personnel in preparation to formulating a fiscal budget. + Responsible along with Regulatory compliance to assure compliance through the laws and applicable standards during internal and external audit programs. + Oversees the evaluation of and suggests alternative methods and procedures in solving problems. + Partners with others to define needs for standardization and ensures the compliance level meets standard operating procedures and applicable standards and regulations. + Organizes, plans, leads and manages quality related projects in alignment with company goals + Facilitates the development and training of immediate staff. + Prioritizes use of staff resources based on global project team input. + Forecasts headcount and resource needs based on these priorities. + Estimates and Oversees staff. + Responsible for communicating business related issues or opportunities to next management level + 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 + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures + Performs other duties assigned as needed **Qualifications / Requirements:** + Bachelor of Science degree or equivalent in a related field + 15 or more years of related experience and/or training; or equivalent combination of education and experience + Clear understanding of applicable standards and regulations + A Master’s degree in an applicable field of study is preferred.` + Knowledge and ability to interpret laws and applicable standards according to product type. + Ability to read, analyze and interpret the most complex documents + Ability to respond effectively to the most sensitive inquiries or complaints + Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors + Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis + Ability to define problems, collect data, establish facts, and draw valid conclusions + Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables + Ability to use PC's and associated software + Ability to effectively deal with representative of various government agencies + Ability to effectively deal with a variety of conflicting issues and diplomatically solves those issues \#LI-Onsite **Required Skills:** **Preferred Skills:** Compliance Management, Consulting, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Succession Planning, Tactical Thinking