Sr. Quality Engineer Job Newark area,California USA,Quality Assurance

Job Title

Senior Quality Engineer

Location

Newark, CA

Department

Quality Assurance Engineering

Reports To

Quality Engineering Manager

Job Summary

The Senior Quality Engineer develops, implements, and maintains plans and methods for controlling the quality of products before, during, and after manufacturing; drives product quality issue resolution and is responsible for inspecting and evaluating the precision and accuracy of production processes, equipment, and finished products.

Primary

Job Responsibilities

Drive product quality issue resolution with the internal team, supplier, and customer.

Identify and escalate production and process issues as found during the internal audit.
Conduct root cause analysis for major product defects, and provide relevant data, analysis, and solutions.
Initiate and implement corrective actions to improve quality and product yields.
Initiate and review customer survey program.
Identify root cause and modes of failure, analyze and present corrective action results with recommendations to internal team and customer.

Manage and document quality control for customer products.

Develop and implement quality control plans, incoming inspections, and test methods for customer products.
Lead the internal audit team by creating an internal audit schedule, reviewing, and providing feedback to auditors regarding audit questions and reports.
Provide internal audit summary to upper management.
Initiate, review, and/or approve inspection‑related documentation; communicate with component suppliers on quality issues and manage Supplier Corrective Action Report (SCAR).
Develop, maintain, and update quality documentation pertaining to quality systems and processes related to production of customer orders.

Evaluate and improve the precision, reliability and accuracy of production processes, equipment, and finished products.

Manage quality deliverables, analyze quality problems, and provide solutions.
Monitor process and yield, manage communication around quality issues; analyze quality trends and propose improvement actions.
Prepare weekly quality reports and dashboards for customers and management.
Develop Process Failure Modes and Effects Analysis (P‑FMEA) to identify potential risks for the manufacturing process and products.
Develop Design Failure Modes and Effects Analysis (D‑FMEA) to identify potential risks to the product and users when required.
Develop and implement the Statistical Process Control (SPC), Statistical Quality Control (SQC), and Measurement System Statistical Analysis (MSA) methodologies to monitor, improve and sustain quality.
Provide support to Unigen OEM product development process.
Conduct an internal audit of the company’s compliance with ISO 9001, 13485, and 14001 and QMS standards, including internal documentation.

Provide support and share expertise cross‑functionally.

Participate with Supply Chain in new vendor selection and qualification, including on‑site audit, by providing the necessary expertise on the company’s quality system and process and customer requirements.
Initiate and review the first article inspection for new customer or product.
Monitor, document, and report suppliers’ performance and assist component engineer in compliance with regulatory and statutory requirements.
Provide support to Unigen OEM product development process: quality data analysis, troubleshooting, continuous improvement initiatives and quality control feedback.
Conduct training and continuous improvement projects based on audit findings to improve process quality, efficiency, and effectiveness.
Develop action plans and coordinate with QA Manager and cross‑functional teams on bringing up the internal Systems to compliance with AS9100, ITAR requirements.
Develop supplier qualification program that meets AS9100 and ITAR requirements.
Coordinate with internal audit team to develop audit program and maintain compliance with AS9100 and ITAR requirements.

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

Minimum Qualifications and Job Specifications

Minimum BS Degree in Engineering, Electronics, or equivalent experience.
Minimum 5 years of related experience in Quality…