NQ- Global QA Senior Engineer / Lead

Role Summary:
The QA Engineer on the Tech Transfer team is responsible for ensuring that all products and processes transferred to the overseas factory meet defined global and local quality standards. This role focuses on quality planning, validation, documentation, and problem-solving throughout the TT lifecycle.

Key Responsibilities (TT Focus):
1. Quality Planning & Documentation:

• Review and localize (if necessary) all transferred quality control plans, inspection procedures, and test methods.
• Collaborate with Process Engineering to ensure FMEA (Failure Mode and Effects Analysis) and Control Plans are robust and implemented.
• Develop and implement Quality Assurance Plans specific to the TT project.

2. Validation & Verification:

• Lead or support IQ/OQ/PQ (Installation, Operational, Performance Qualification) or PPAP (Production Part Approval Process) activities for transferred equipment and processes.
• Oversee First Article Inspection (FAI) process for transferred products/components, ensuring all dimensions and specifications are met.
• Conduct Measurement System Analysis (MSA/GR&R) for key inspection and test equipment.

3. Quality Control & Monitoring:

• Establish and monitor key quality metrics (e.g., yield, defect rates, scrap rates) during pilot runs and initial production.
• Implement Statistical Process Control (SPC) where applicable to monitor process stability.
• Manage non-conforming materials (NCM) and lead disposition processes.

4. Problem Solving & CAPA:

• Lead root cause analysis (RCA) and implement corrective and preventive actions (CAPA) for any quality issues arising during TT.
• Facilitate 8D problem-solving methodology with cross-functional teams.

5. Training & Compliance:

• Provide quality-related training to local production and quality personnel.
• Ensure compliance with global QMS, customer-specific requirements, and relevant industry regulations.