Job Summary: The Quality Engineer develops, implements, and maintains plans, and methods for controlling the quality of products before, during and after manufacturing and is responsible for inspecting and evaluating the precision and accuracy of production processes, equipment, and finished products. Reports to Senior Manager of QE and QA located in Newark, CA.
Primary Job Responsibilities:
1. Customer Requirement & MPI Approval
Review Customer requirement and company Manufacturing Process Instructions (MPI) to ensure all customer requirements are accurately reflected.
Determine, create quality-critical inspections for First Article and Quality Inspection process.
Conduct risk assessments and determine actions for MPI or Quality Alerts.
2. Process Quality Control & Defect Prevention
Plan and conduct process audit, review to ensure for accuracy (Man, Method, Machine, Material).
Lead root cause analysis (RCCA) for process defects and drive corrective actions with cross-functional teams.
Review and close out line-stop events due to material, skill, method, machine, or unresolved CAPA issues.
Stop the line if major quality risks are identified for improvement.
Provide technical support for quality-related issues in production and inspection.
3. Customer Support & Communication
Act as a customer representative for quality matters: handle quality reports, customer complaints, CAPA, audits/visits, and meetings.
Prepare and submit FAIR, CofC, and other customer-required documentation.
Ensure timely and effective communication and support to customers.
4. Quality Data Analysis, Reporting and Improvement
Analyze quality data (defects, yield, RCCA, etc.) and prepare internal and customer-facing reports.
Drive continuous improvement initiatives for process yield, defect reduction, and compliance.
Ensure compliance with ESD, regulatory, and customer-specific requirements.
Participate in and support internal and external audits.
Develop and implement the Statistical Process Control (SPC), and Measurement System Statistical Analysis (MSA) or other methodologies to monitor, improve and sustain the quality.
5. Supplier Quality Engineering
Qualify new suppliers and conduct supplier audits to ensure compliance with Unigen and customer requirements.
Review and approve supplier PPAP, FAI, and other qualification documentation.