Sr. Quality Assurance Engineer

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:

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.

Job 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 fulfill the applicable Global and Corporate procedures compliance to international standard and regulations (i.e. ISO 13485, FDA 21 CFR part 820, etc.)
• Reviews and approves protocols summaries and all documents related with process validation following standard operating procedures, company policies and procedures.
• Develops and impart courses related with topics of process validation.
• Acts as Initial Impact Assessment (IIA) Approver in PegaSystems Change Control.
• Leads quality documentation, records management, and electronic data control.
• 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.
• Provides technical guidance to QA Engineers/Technicians.

• Bachelors in engineering or technical sciences
• Masters degree (preferred).

• Strong knowledge of ISO 13485, FDA regulations.
• Certified Quality Engineer and or Green Belt certification (preferred).
• Proficient in quality tools and advanced statistical techniques.
• Proficient in process, software and test method validations.
• Strong English communication skills (oral and written).
• Leadership and team supervision experience.