Quality Engineer
About this position
Responsibilities
• To ensure compliance with the Quality Management System in place, such as ISO 13485, 14001, FDA 21CFR Part 820, and other relevant standards.
• To carry out duties in accordance with Quality, Environmental Health, and Safety policies of PMTH and GMP, contributing to the achievement of company goals and KPI’s, including analysis of data for continual improvement.
• To ensure all products and manufacturing processes quality can meet product specification.
• Manage the effectiveness of quality control plan implementation in the manufacturing, ensuring all manufacturing process controls are in place and effectively utilized.
• Closely monitor the performance of key quality indicators and initiate, deploy, and implement plans or measure to meet the goals and key KPIs.
• Lead team to review, analyze daily process issues and drive for scrap and production yield improvements.
• Lead team to investigate and provide disposition for rejects, non-conforming parts from manufacturing processes, inspection gate, feedback, customer quality notification and returned parts. Provide stop build, stop ship and other containment solution decisions to prevent risk of defective parts escaping to customers.
• Manage supplier quality to ensure incoming material quality, supplier QMS and other activities are in accordance with Molex supplier management policies.
• Handle customer complaint, lead for defect investigation, root cause analysis, implementation effectiveness of corrective action, and prevention. Complete CAPA report and communicate with customer until the case is closed.
• Create, review and update Inspection Instructions, Inspection Plan, Workmanship Standard, Quality Control Plan, etc. Ensure appropriate maintaining of the quality records.
• Manage Change, deviation and nonconformance in manufacturing to ensure QMS and customer requirements are satisfied.
• Engage AQP at early product development or production transfer phase to better understand the new products and share knowledge for better AQP development.
• Initiate, participate in CIP projects for manufacturing improvements ensuring achieving of all plant KPIs – SQDC.
Requirements
• Degree in Industrial Engineering, Mechanical Engineering, Quality, or related discipline.
• Proven experience in Quality Engineering, Quality Assurance, or a similar role at least 3 years.
• Working knowledge of ISO 9001 as a basic, ISO 13485 is desirable.
• Strong interpersonal skills, good command of communication in Thai/English.
• Strong analytical and problem-solving skills.
• Good knowledge of QC core tools, CAPA, FMEA, Control Plan.
• Proficient in Microsoft Office, basic GDT, or technical drawing understanding.
• Advantageous to understand statistical tools, SAP, ISO-Process Auditing Experience.