STEC QA Engineer

Job description

About Company SHL Medical is a 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. Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine. Job Overview This position is to (a) drive supplier quality performance, including new product development and product quality improvement (b) work closely with cross-functional stakeholders and suppliers (c) Performing quality system audits and development good partnership with suppliers (d) ensures the delivery of high quality product which meet the regulatory requirements and customer expectations 這個職位的目的是 (a) 提升供應商品質績效，包括新產品開發和產品品質改進 (b) 與跨職能部門的利害關係人和供應商緊密合作 (c) 進行品質體系審核，並與供應商建立良好的合作夥伴關係 (d) 確保交付符合法規要求和客戶期望的高品質產品 Responsibilities • Be responsible for supplier and part qualification in accordance with pre-defined specification and qualification system requirements • Work closely with quality & engineering team to establish critical-to-quality, acceptance criteria and testing requirements to outsourced suppliers • Perform periodic supplier evaluation, annual audit and ad-hoc on-site verification • Manage the evaluation of supplier’s performance and supplier’s continuous improvement program • Coordinate incoming verification on outsourced material and purchased component to verify quality requirements are met • Ensure close-loop of corrective and preventive action (CAPA) process on reported issues. • Actions taken should be proportionate to the risk associated with the use of the component, or product. • Carry out other duties as assigned. • Assign above job tasks by staffing qualification / personal ability / organization needs. • 負責根據預先定義的規範和認證系統要求對供應商和零件進行認證。 • 與品質和工程團隊緊密合作，制定外包供應商的關鍵品質標準、驗收標準和測試要求。 • 執行定期供應商評估、年度審核和臨時現場驗證。 • 管理供應商績效評估和持續改善計畫。 • 協調外包材料和採購組件的來料驗證，以確保其符合品質要求。 • 確保對已報告的問題採取閉環糾正和預防措施 (CAPA) 流程。 • 採取的措施應與使用組件或產品相關的風險相稱。 • 執行指派的其他任務。 • 依據人員資格/個人能力/組織需求分配上述工作任務。 Qualification ‧ BS degree above or equivalent technical work experience. ‧ Clear / logical thinking with strong organization and communication skills ‧ Proficient problem solving skills. ‧ Working knowledge of Microsoft Office. ‧ Experience in the medical device industry is preferred. ‧ Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred. ‧ CQT (certified quality technician), CQE (certified quality engineer) is a plus. ‧ Six sigma green belt or black belt is a plus. ‧ 工程學士學位以上或品質/製程相關工作經驗。 ‧ 具有清晰/邏輯思維和良好的組織和溝通能力。 ‧ 熟練的解決問題能力。 ‧ 熟悉Microsoft Office軟體。 ‧ 具有醫療器械行業經驗者優先考慮。 ‧ 熟悉法規合規要求：GMP、QSR、和ISO 13485者優先考慮。 ‧ 持有CQT（認證品質技術員）、CQE（認證品質工程師）證書者優先加分。 ‧ 擁有六標準差綠帶或黑帶證書者優先加分。