Sr. Quality Asurrance Engineer

hace 2 semanas

Ciudad Juárez, México BD A tiempo completo

**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.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.**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**:

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