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.
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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
1. 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.
2. Manage and document quality control for customer products.
Develop and implement quality control plans, in-coming inspections, and test methods for customer products.
Lead the internal audit team by creating an internal audit schedule, review, and provide feedback to internal 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.
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3. 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 the potential risks for the manufacturing process and products.
Develop Design Failure Modes and Effects Analysis (D-FMEA) to identify the potential risks to the product and the 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 the 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.
4. Provide support and share expertise cross-functionally
Participate with Supply Chain in new vendor selection and qualification, including an 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 coordinates 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.
Coordinates with internal audit team to develop audit program and maintaining the 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 Engineering and Quality Control in a PCBA and Mechanical EMS (Electronic Manufacturing Services) environment.
Experience working in an ISO 9001 environment.
Preferred IPC-610 and J-STD 001 Certified personnel.
Other Qualifications
Excellent knowledge of quality management and improvement practices and programs such as Six Sigma, Continuous Improvement, TQM, Good Manufacturing Practices, ISO, IATF, IPC, AS9100, ITAR etc.
Problem Solving skill with proficient knowledge of RCA, CAR closed loop and applicable regulatory compliance issues regarding manufacturing.
Excellent understanding of Quality Management and Engineering, PCBA, and mechanical manufacturing processes including experience in developing and performing new process qualification.
