Quality Engineer

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.

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.

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.

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.

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.

Monitor supplier performance (incoming quality, delivery, responsiveness) and drive improvement initiatives.

Manage supplier non-conformances: issue SCARs, lead root cause analysis, and verify effectiveness of corrective actions.

Collaborate with Purchasing and Engineering to resolve supplier-related issues and support new product introduction (NPI).

Maintain Approved Supplier List (ASL) and ensure supplier compliance with regulatory and customer standards.