Quality Engineer

Unigen•Newark, CA

40d•$75,000 - $95,000•Onsite

About The Position

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.

Requirements

Minimum BS Degree in Engineering, Electronics, or equivalent experience
Minimum 2 years of related experience in Quality Engineering and Quality Assurance, Quality Control in electronics/PCBA manufacturing.
Bachelor’s degree in Engineering, Quality, or related field.
Strong knowledge of quality systems (e.g.: ISO 9001, AS9100, etc.), FMEA, RCCA, 8D Report and process control.
Experience with customer audits, CAPA, and quality reporting.
Excellent analytical, problem-solving, and communication skills.
Ability to work cross-functionally and drive results in a fast-paced environment.

Responsibilities

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.
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.
Other duties and responsibilities related to Quality Engineering function, when assigned.