Manufacturing & Operations

Quality Engineer

November 26, 2024

Job Description

Monitor product quality; implement quality control (IQC, IPQC, PSA) and improvement to achieve product quality targets. Lead new project introduction (NPI project) in quality activities. Conduct supplier audit surveillance and quality improvement for incoming raw materials. Lead workshop improvement activities to improve product quality.

Position Location
QCB Thailand
Responsibilities
Lead project team on new project quality improvement before mass production.
Participate in new product trials, follow product quality, and provide personal advice from a quality perspective.
Act as the quality contact window with customers on new project quality.
Lead new project gate review and quality risk assessment.
Establish the requirements of measurement & testing, and follow up on implementation including appropriate SPC control.
Manage data collection and analysis.
Review product manufacturing environment requirements.
Set up visual specifications, including sampling plans for Incoming Inspection (IQC), In-Process Inspection (IPQC), and Final Inspection (PSA).
Lead efforts to resolve customer quality issues, analyze and handle material quality issues, and follow up on corrective actions.
Audit the production line according to the audit plan.
Establish, maintain, and improve work instructions, inspection checklists, and train inspectors.
Participate in validation processes and internal audits according to ISO 13485.
Conduct CME & CDA validation, and CME & OFA monthly monitoring and reporting.
Prepare all quality reports, including FAI reports and inspection reports.
Requirements
Male/Female, age 25-35 years old.
Bachelor’s degree in Engineering or Science.
Over 5 years of relevant work experience in QC/QA.
Knowledge of QC-7 tools, PFMEA, APQP, PPAP, 8D, SPC, 5Why, etc.
Knowledge of ISO 13485 and ISO 14971 is an advantage.
Proficiency in using basic measurement devices.
Good command of English for communication.
Proficient in MS Office software applications.
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