QA - Supplier QA Engineer

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the Unites States. 【Job Overview】 The Supplier QA Engineer is responsible for • To drive supplier quality performance, including new product development and product quality improvement • Overseeing supplier quality and establishing quality control objectives • Ensuring the supplier fulfill regulatory and SHL’s requirements • Performing quality system audits and development good partnership with suppliers 【Main Responsibilities】 • Ability to manage the quality of products and services provided by suppliers, ensuring compliance with company standards and requirements. Independently conduct investigations on abnormalities, analyze potential process risks, identify root causes, and drive improvements to continuously enhance supplier quality performance. • Experience in planning and executing supplier evaluations and audits, including document reviews and on-site inspections. Coordinate and support second-party and third-party certification audits. Evaluate supplier responses to deficiencies and lead supplier quality improvement initiatives. • Familiarity with quality management systems and relevant standards (e.g., SOPs, GMP). Capable of developing and maintaining quality documents and training programs. Provide quality and GxP training to internal teams and suppliers to ensure audit readiness. • Skilled in data analysis to drive continuous improvement projects aligned with departmental and company goals. • Strong communication and coordination skills to effectively collaborate with cross-functional teams and suppliers, resolve quality issues, and report quality status and audit findings to senior management. • 具備管理供應商產品及服務品質的能力，確保其符合公司標準與要求。能獨立展開異常調查，分析製程風險，找出根本原因並推動改善，促使供應商持續提升品質表現。 • 能規劃與執行供應商評估及審核，包括文件審查、現場稽核，以及協助安排第二方與第三方認證稽核。能評估供應商缺失回應並帶領品質改善計劃。 • 熟悉品質管理系統及相關標準（如SOP、GMP等），能制定及維護品質文件與培訓計劃，並提供內部與供應商的品質及GxP培訓，確保稽核準備度。 • 擅長運用數據分析推動持續改善計劃，以達成部門及公司目標。 • 具備良好的跨部門及供應商溝通協調能力，能有效解決品質問題，並能向高層管理者報告品質狀況與稽核結果。 【Qualification】 • A bachelor's degree in engineering, manufacturing, technology-related fields or other science-related fields is required. • At least three years of experience in quality assurance, preferably in the medical device, biopharmaceutical, or other regulated industries. • Familiarity with 21 CFR part 820, ISO 13485, and cGMP is a plus. • Internal audit training in ISO 13485 / ISO 9001 or equivalent is a plus. • Experience managing external quality audits is a plus. • Familiarity with quality tools, audit techniques, and problem-solving skills is a plus. • Ability to collaborate well within a cross-departmental team and independently manage workload. • Good interpersonal, written and verbal communication skills in both English and Chinese. • 具備工程、製造、技術相關或其他理工科相關領域的學士學位。 • 至少三年以上品質保證相關經驗，醫療器材、生物製藥或其他受規管產業經驗者優先。 • 熟悉21 CFR Part 820、ISO 13485及cGMP者佳。 • 具備ISO 13485 / ISO 9001內部稽核培訓經驗者優先。 • 具管理外部品質稽核經驗者佳。 • 熟悉品質工具、稽核技巧及問題解決能力者優先。 • 能良好協作跨部門團隊，並具備獨立管理工作負荷的能力。 • 具備良好的人際關係、中文及英文書面及口頭溝通能力。