Job Function Senior NPI Quality Manager – Horizontes Site (Ciudad Juarez) Job Sub Function Quality Assurance Job Category People Leader Locations Ciudad Juarez, Mexico; San Angelo, Texas, United States of America Purpose Plan, coordinate, and direct quality assurance programs to ensure the continuous production of products that meet established standards. The role has a major impact on business results and includes management responsibility for a team of quality professionals. Key Responsibilities Collaborate with NPI, operations, and engineering to develop, conduct, and approve validation strategies for products and processes. Lead or support quality improvement initiatives, including PDCA, Six Sigma, Kaizen, Lean, and benchmarking to enhance quality and reduce costs. Review and approve engineering change orders and monitor quality costs to maintain compliance with medical industry standards. Ensure compliance with QSRs, ISO 13485, and other standards; prepare for regulatory audits and review audit observations. Maintain required documentation of quality assurance activities and conduct periodic line audits to evaluate GMPs and production controls. Define, monitor, and manage the department’s central budget and costs. Lead and attend NC Review meetings, and oversee investigations, CAPAs, and customer complaints. Manage product and process qualification, including validation strategies, risk assessments, and maintenance of PFMEAs and quality control plans. Collaborate with quality leaders to identify required skills, conduct strategic planning, and allocate resources. Provide supervision, mentoring, coaching, performance review, and succession planning for team members. Maintain health, safety, and environmental practices, ensuring compliance with all applicable regulations. Perform additional duties as assigned. Qualifications / Requirements Minimum bachelor’s degree in mechanical, electrical, industrial engineering, or applicable science. Master’s or Ph.D. preferred. 8‑10 years of related experience or demonstrated performance. Experience with computer database management. Effective negotiation and communication skills in English, both written and oral. Hands‑on problem‑solving ability and sound judgment. Certifications such as CQA, CQE, CQM (preferred), CBA, or MBB. Expected Base Pay Range $150,000 (United States). Candidates hired outside the United States will receive compensation and benefits in accordance with their local market. Application Deadline Job posting is anticipated to close on 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. Accessibility Statement Johnson & Johnson is committed to providing an inclusive interview process. If you have a disability and would like assistance, contact us via . #J-18808-Ljbffr
Senior Npi Quality Operations Manager
JOHNSON & JOHNSON MEDTECH
Ciudad Juárez, Ciudad Juárez
Publicado hace 4 días
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