**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:
Responsible for managing the Master Validation Plan and ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and corporate procedures. Oversees validation documentation, change control assessments, and quality records. Leads CAPA investigations, continuous improvement initiatives, and provides technical guidance to QA teams. Supports training, test method development, and product lifecycle activities.
**Responsibilities**:
- Act as Site Validation Lead for BD Juarez
- Responsible to define and manages the Master Validation Plan Metrics.
- Responsible to ensure that all validation process activities fulfil...