工作內容:
1. 熟悉ATE之PCB板電子零件料件、依BOM list搜尋零件供應商、詢比議價,及回報PM
2. 依客戶及製程需求,搜尋替代料,並洽詢AE替代可能
3. 規劃零件供應鏈系統
4. 掌控專案進度、零件交期管理
5. 材料異常之退換及扣款事宜
6. 與美國RDA之PM、採購、倉庫、RD、AE等協調溝通聯繫,確認所需零件規格、數量
7. 其他主管交辦事項
1. Familiar with electronic components for ATE PCB boards. Search for component suppliers based on the BOM list. Collect quotations, negotiate prices, and report to the PM.
2. Search for alternative materials according to customer and process requirements, and consult AE about the availability of alternatives.
3. Plan the component supply chain system.
4. Control project progress and manage component delivery schedules.
5. Handle returns, replacements, and deductions for material abnormalities.
6. Coordinate and communicate with the US RDA's PM, purchasing, warehouse, RD, AE, etc., to confirm required component specifications and quantities.
7. Other tasks assigned by supervisors.
需求條件:
1. 熟悉電子零組件,具SMT採購經驗3年以上佳
2. 熟 Office作業,尤須Excel能力佳。 具ISO相關作業經驗
3. 具BOM 表解析能力
4. 數字觀念清楚、細心積極負責,能獨立作業佳
5. 具中等以上之英文能力,日常工作需與美國RDA之採購、PM、Project Engineer、工程等單位合作,經常以英語email或視訊會議溝通討論
1. Familiar with electronic components, with preferably over 3 years of experience in SMT procurement.
2. Proficient in Office tools(especially excel skills), with experience in ISO-related tasks.
3. Ability to interpret BOM (Bill of Materials) tables.
4. Detail-oriented, proactive, and able to work independently.
5. Possess intermediate or above English proficiency. Need contact via e-mail and web meeting with US HQ teams such as Purchasing, PM, Project Engineer, Engineering for spec clarification.
**此職位上班地點為保瑞藥業中壢廠,交通方便
**面試提問主軸包含國外主管機關驗廠實例 (FDA),非常歡迎具製藥/生技/醫材業背景人選!
Job Summary:
1.Provide QA oversight CDMO Projects and Site compliance activities with quality oversight for commercial batches.
2.Achieve QA department goals and company objectives.
Job Duties and Responsibilities:
1.CDMO Projects - Quality oversight on quality activities including review and approve documentation, change controls for trial/submission batches.
2.Supplier Management - Manages Supplier Qualification, Audit program and Approved Supplier List
3.Audit Management - Manages internal and external audit activities, reviews and supports site audit readiness strategy, oversees preparedness for audits from agency (FDA, TFDA), or external audits from the sponsors/customers, support regulatory actions follow-ups on audit non-conformance resolutions and CAPA follow-ups.
4.To provide oversight for site self-inspection programs and implement continuous improvement initiatives.
5.Management of Quality Assurance Agreements (QAAs) – Establish and ensure current QAAs is up-to-date to support CDMO operations.
6.Site Score cards Management – Coordinate and report site quality metrics and organize quality councils
7.Oversight on annual CGMPs refresher training, coordinate periodic GEMBA walks and support site QIP programs to ensure site compliant to current FDA CFRs, TFDA regulations and customers requirement per Quality Assurance Agreements established for CDMO activities
8.Ensure personnel training/ qualification and curriculum are aligned to job roles and responsibilities
9.Others: Any additional assignment requested by Supervisor.
Responsible for handling customer quality complaints, act as a liaison with other company departments worldwide and interface with OEM factories regarding quality aspects
Provide 8D report to Asian customers, evaluate corrective actions for all complaints and assure all of actions are well followed in production process.
On specific projects, work closely with PM teams to launch of new products. Such activity would include process check, DFMEA/PFMEA, Q-flow chart check and first-article inspection.
Evaluates the supplier processes and process controls to ensure product quality and reliability is compliant. Develops supplier capability with conducting continuous improvement actions.
Involved in various audits regarding to connector production process, quality system and plating process.
The further tasks will be defined regarding your own skills and team's requests
Working location and Business travel: Based in Taoyuan with several business trips in east of China and some in Europe.