Quality Engineer

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 the 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, incoming inspections, and test methods for customer products.

Initiate, review, and / or approve inspection-related documentation; communicate with component suppliers on quality issues and manage Supplier Corrective Action Report (SCAR).

3. Evaluate and improve the precision and accuracy of production processes, equipment, and finished products.· Manage quality deliverables, analyze quality problems, and provide solutions.

• Monitor process and yield, and manage communication around quality issues.· Provide support to 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.
• Conduct training and continuous improvement projects based on audit findings to improve process quality, efficiency, and effectiveness.

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.

Required Education Experience : 1. Minimum BS Degree in Engineering, Electronics, or equivalent experience2. Minimum 10 years of related experience in Supplier, Process, and Customer Quality areas.

3. Minimum 3 years serving as a Lead ISO internal auditor Other Qualifications : 1. Excellent knowledge of quality management and improvement practices and programs such as Six Sigma, Continuous Improvement, TQM, Good Manufacturing Practices, ISO, IATF, IPC, etc.

2. Strong knowledge of all applicable regulatory compliance issues regarding manufacturing.3. Excellent understanding of Quality Management and Engineering, PCBA, and mechanical manufacturing processes including experience in developing and performing new process qualification.