醫材領導廠 - 品管經理

【Client Description】

全球醫療器材領域擁有領導地位的優質製造商

【Candidate Profile】

• 3+ years of hands-on quality management experience in manufacturing, preferably medical device or regulated industries
• Strong capability in statistical analysis (SPC, trend analysis, risk signals) and data-driven decision making
• Experienced in writing and reviewing English quality reports and technical documentation
• Certified or trained in Six Sigma, with practical experience in LEAN or continuous improvement projects
• Proven ability to lead, train, and develop quality engineers and inspectors in a structured quality system

【Responsibilities】

• Lead quality control planning, KPI setting, and performance review for plant-level QC team (13+ members)
• Drive annual quality improvement projects, including SPC analysis, risk trending, and corrective actions
• Review, write, and approve English quality reports covering inspection results, deviations, and improvement actions
• Manage customer complaints, root cause analysis (RCA), CAPA execution, and effectiveness verification
• Validate and document engineering changes, process adjustments, and quality system updates per medical device requirements