SENIOR NPI QUALITY OPERATIONS MANAGER

Job Title SENIOR NPI QUALITY MANAGER Location Ciudad Juarez, Mexico Purpose Plans, coordinates and directs quality assurance programs designed to ensure the continuous production of products consistent with established standards. At this level, the position has a major impact on business results and typically has management responsibility for a group of professionals under its charge. Responsibilities New Products / Process Introduction Collaborates with NPI and the operations and engineering departments to develop, conduct and approve validation strategies of products and processes. Promotes and supports the implementation of quality, product and process improvement projects. Reviews and approves engineering change orders (ECOs). Business Improvement Leads or supports quality improvement initiatives such as process and product characterizations leading to continuous improvement / cost. Reviews / analyzes the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs. Conducts benchmarking to develop more effective methods to improve quality. Establishes and formulates quality metrics to maintain quality assurance objectives and alignment with plant objectives. Supports the development of quality engineering and quality compliance with appropriate skills for new product introduction, and product life cycle management. Compliance / Regulatory Reviews / analyzes whether current products and processes comply with standards, such as QSRs, ISO 13485, etc. Leads preparation activities for regulatory agency audits, including active participation as SME or Escort (e.g., FDA, JJRC, BSI, etc). Reviews and approves responses to internal or external audit observations to ensure compliance with internal procedures and applicable regulations. Establishes and properly maintains required documentation of quality assurance activities and/or quality systems. Ensures periodic line audits are conducted to evaluate GMPs, production controls, batch segregation and process audits in accordance with JJPS. Reviews results of area audits to ensure corrective and preventive actions are appropriate. Finance Defines, monitors and manages the department's central budget/cost. Product Quality, Control & Disposal and Performance Standards Leads and attends NC Review meetings as a member of MRB. Reviews and approves investigations, bounding, documentation, review and approval of nonconformances (NCs), corrective and preventive actions (CAPAs), customer complaints and escalation of quality issues as applicable. Responsible and owner of material identification, material segregation, classification of defect types, including the successful application of these techniques in day to day manufacturing. Gives direction and allocates resources for the resolution of complex (technically) problems associated with the manufacturing process at a local or franchise level. Product / Process Qualification Reviews and approves process validation strategies. Ensures that periodic maintenance and review of CTQs is performed on the manufacturing process to ensure continued customer satisfaction. Approves the review and maintenance of PFMEAs, Quality Control Plans, Process Instructions, and additional manufacturing documents. Supports the development and proper implementation of process monitoring and control methods consistent with the risk level of the process/product. Promotes the use of innovative tools for timely risk detection and mitigation. Determines the effectiveness of these techniques on previously implemented improvements. Responsible for and owns the risk assessment process including the conduct, documentation, review or maintenance of current risk and hazard analysis documentation such as process FMEA given product/process changes. Strategy Collaborates with other quality leaders to identify required quality engineering skills and competencies to enable execution of the strategic vision. Conducts strategic planning with site leaders and product engineering team. Teams with other functions to establish business priorities and resource allocation. People Provides supervision, mentoring, coaching, performance review, development plans and succession planning for others (where applicable). Responsible for communicating business related issues or opportunities to next management level. Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. 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 Minimum Bachelor's degree, preferably in engineering: Mechanical, Electrical, Industrial or applicable science. Master's or Ph.D. in applicable science is preferred. 8-10 years of work experience or demonstrated performance. Computer package management. Ability to deal effectively and negotiate with representatives of various government agencies and auditing agencies. Excellent communication skills in English both written and oral. Ability to perform hands‑on problem solving; highly desired. Certification such as CQA, CQE, CQM (preferred), CBA, MBB or BB a plus. Required Skills Compliance Management Corrective and Preventive Action (CAPA) Cross‑Functional Collaboration Developing Others Fact‑Based Decision Making Giving 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) Tactical Thinking Team Management Preferred Skills Compliance Management Corrective and Preventive Action (CAPA) Cross‑Functional Collaboration Developing Others Fact‑Based Decision Making Giving 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) Tactical Thinking Team Management Compensation The expected base pay range for this position is $150,000. Closing Date 05/08/2026 Equal Opportunity Statement 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 have a disability and would like to request an accommodation, external applicants may contact us via ; internal employees can reach out to AskGS to be directed to the accommodation resource. #J-18808-Ljbffr