Manufacturing Quality Engineer

Manufacturing Quality Engineer will be responsible for ensuring in-process product quality, driving root cause analysis of quality issues, and implementing corrective actions. This role plays a critical part in developing and qualifying robust manufacturing processes that meet customer and regulatory requirements at our Fremont Factory.

In-Process Quality Control:

• Collaborate with Production and Engineering to define and maintain critical quality parameters and control limits
• Develop and implement in-process inspection standards, control plans, and quality monitoring systems.

Non-Conformance (NC) Handling:

• Manage the identification, documentation, and disposition of non-conforming material.
• Lead cross-functional teams to evaluate and contain non-conforming products in a timely manner.
• Drive data collection and analysis of NC trends to support continuous improvement efforts.

Root Cause Analysis & Corrective Action (RCA/CA):

• Lead structured problem-solving activities using tools such as 5 Whys, Fishbone diagrams, and FMEA.
• Coordinate cross-functional teams to define root causes and implement corrective/preventive actions (CAPA).
• Monitor and verify the effectiveness of implemented actions to ensure sustainable improvements.

Process Qualification & Validation:

• Develop and execute process qualification plans when introducing new processes or equipment.
• Collaborate with Engineering to define quality requirements for new or modified equipment and processes.
• Review and approve process validation protocols, reports, and supporting data.

Continuous Improvement & Change Management:

• Drive process improvements using Lean, Six Sigma, or other quality methodologies.
• Participate in Kaizen events and support quality training programs for production staff.
• Participate in Engineering Change Control (ECC) reviews and ensure proper risk assessments and validations are completed.
• Provide process specific Technical Training to the technicians as part of CI efforts.

Documentation & Compliance:

• Ensure all quality documentation is accurate, complete, and compliant with industry standards (ISO 9001 & AS9100).
• Support internal and external audits, including customer and regulatory audits.
• Maintain records for traceability, calibration, inspection results, and process changes.