**Job Description Summary** Sr. Quality Assurance Engineer leads quality initiatives, develops test methods, and ensures compliance with ISO/FDA standards. Drives root cause analysis, CAPA, and continuous improvement in manufacturing processes. Supports new product introductions and validation at all levels. **Job Description** P3-11554 **Job Summary** The Sr. QA Engineer: + Develops methods and metrics for Key Quality Indicators. + Analyzes data and distributes reports to internal departments and BD divisions. + Leads quality documentation, records management, and electronic data control. + Drives training and awareness in quality procedures. + Leads root cause analysis and CAPA (Corrective and Preventive Actions). + Implements continuous improvement programs to reduce defects and risks. + Participates in test method development, new product development, complaint handling, and change control. + Supports compliance with ISO, FDA, and corporate standards. + Leads quality aspects of new product introductions. **Job Responsibilities** + Provides technical guidance to QA Engineers/Technicians. + Participates in A3 creation for Quality. + Applies intermediate statistical methods (e.g., regression, ANOVA). + Manages non-conforming product disposition and MRB actions. + Designs quality studies and reports. + Approves/supports validation protocols (IQ/OQ/PQ). + Acts as SME for process/test method validations. + Leads CAPA assessments and improvements. + Develops sampling plans and understands OC curves. + Handles customer complaint evaluations. + Leads Nonconformance (NC) processes. + Develops Control Plans and Test Methods. + Acts as Initial Impact Assessment (IIA) Approver in PegaSystems Change Control. **Knowledge & Skills** + Familiarity with ISO 13485, FDA regulations. + Certified Quality Engineer (preferred). + Proficient in quality tools and statistical techniques. + Experience in root cause analysis, test method development, and process validation. + Strong English communication skills (oral and written). + Leadership and team supervision experience. Required Skills Optional Skills . **Primary Work Location** MEX Juarez Homecare **Additional Locations** MEX Juarez Healthcare **Work Shift** Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.