Quality Engineer

Quality Engineer

Responsible for the key Quality Management System (QMS) operation processes, cooperating with the whole site to maintain and improve QMS. Work closely with the customers on their concerns/feedback to improve customer satisfaction continually. Provide Assist/support other quality functions concerning product and process quality.

Responsibilities

• Maintain and improve document control process, ensuring the controlled documents are reviewed, approved and utilized in timeliness manner.
• As the Champion of Document Control System (MasterControlTM), set up workflows to route the document for review, implement E-forms as determined by management team and work with the supplier to resolve any issues arising during daily operation.
• Maintain, monitor, promote and improve the corrective action process.
• Conduct, coordinate and support on-site/remote internal/external audits and evaluate audit finding.
• Maintain internal auditor training program and keep the internal auditor team competent.
• Facilitate customer related processes such as complaint handling, information inquiry, etc.
• Assisting in Supplier Management Activities.
• Develop, generate and communicate QMS metrics and Quality Department data to management and other stakeholders.
• Assist Quality Manager in preparation of Management Review presentations.
• Supports the efforts or tasks which need the Quality Department involvement or participation, including but not limited to nonconforming material handling, quality inspections, calibration, yield trending, etc.
• Performs related duties and special projects as assigned.

Requirements

• Bachelor’s Degree in Engineering or related discipline is required, with 3-5 years of experience in a manufacturing environment
• 3 - 5 years' experience in establishing/maintaining an ISO 9001-compliant Quality Management System
• Knowledge and experience of using structured problem-solving methods such as 6M, 5Why, or other types of integrated problems solving and root cause analysis
• Trained/Certified Lead Auditor/Internal Auditor per ISO 19011
• Knowledge and experience in documentation management function, including proficiency with MS Office, understanding engineering drawings & specifications, concept of controlled documents, information technology enhanced document control systems, etc.
• Experience with SPC, MSA, FMEA and Control Plan
• Experience with ISO 13485 or detailed experience in leading QMS to automotive or aerospace standards
• Must be able to utilize all hand tools, micrometers, optical comparator, and other related equipment with optimal accuracy.
• Experience of using/maintaining MasterControlTM