Sr. Quality Asurrance Engineer

hace 3 días

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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