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https://columbiasportswearcompany.wd5.myworkdayjobs.com/Columbia_Career_Site/job/Taipei-City-Taipei-City-Taiwan-Region/Product-Compliance-Manager_R-016887
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Product Compliance Program Manager is responsible for managing Product Compliance, Chemical management program including RSL/MRSL management and wastewater management, leading company wastewater and product safety compliance standards throughout the global manufacturing base, with the goal to meet customer requirements, reduce/eliminate risk to workers and consumers, the environment, the company and brands.
【Product Compliance Program Development and Deployment 】
• Manage corporate Restricted Substance List (RSL) policy implementation and product compliance failure remediation with vendors partners and internal business partners, supplier product compliance tracking and reporting.
• Manage corporate Chemical Management Policy deployment, aligning with industrial practice and meet the requirement.
• Support research on sustainable chemistries or green chemistry alternative if require
• Develop branded fiber process to ensure the brands meet global labelling regulation and requirements
• Develop global labelling manual and work with internal stakeholders to create standard operation process
• Support claims validation for wholesale account requests
• Track Wastewater global regulation and industrial standard, meeting country regulation and align with industrial practices.
• Lead the remediation if any Wastewater compliance failure, find out the root cause by partnering with vendors, provide leadership and make recommendation to minimize the business impact.
• Assess international market program requirements and establish future process to support business growth
• Advance Global Product Compliance Team goals and objectives through additional projects and cross-functional support as needed
【Supply Chain Product Compliance and Wastewater Management Performance Assessment】
• Execute the Chemical and Wastewater Management assessment tools (Higg FEM) to supply chain, driving the completion and verification rate improvement to give visibility of supply chain performance.
• Manage and track factory KPI to measure compliance performance including wastewater discharge permit and support the integration with material sourcing system.
• Conduct onsite factory audits for chemical management, RSL and wastewater compliance when necessary.
【Supply Chain Engagement, Training and Improvement】
• Identify and analyse the performance gap of supply chain to develop required training program, collaborating with manufacturing partners including liaison office material team and production. Provide recommendation to solve vendor's challenge during the program implementation.
• Engage internal and external stakeholders building relationship with the company manufacturing partners and the industry including testing service providers, GIZ fabric and other brands
• Lead vendor meeting to communicate vendor performance and make recommendation of score card improvement.
• Communicate and deliver technical RSL and Wastewater training to internal and external stakeholders, acting as technical center to business partners for product compliance and wastewater requirement.
• On-boarding the new hire from liaison offices and new vendors, introducing of company compliance policy and process
• Manage capacity building programs by collaborating with business partner and service providers, including stakeholders' engagement, program status tracking, make recommendation of improvement, negotiate with vendors or manufacturing partners to adopt required change.
This job description is not meant to be an all-inclusive list of duties and responsibilities, but constitutes a general definition of the position's scope and function in the company.
工作詳細內容Job descriptions:
Responsibilities & Authorities:
1. Reponsible for Hazardous Substances Management System including:
− Periodically update the applicable regulations (RoHS/REACH/SVHC/POPs/ED/PFAS/BPA/Latex/EU - CMR/Cal Prop 65) for medical devices.
− Capable of conducting risk assessment and evaluating the impact of new or revised regulations/standards.
− Collect and obtain the declaration, report, or evidence from Suppliers for compliance.
− Establish and manage the hazardous Substance Database.
− Complete the hazardous substances information for components and products approval.
2. Responsible for quality oversight and execution for medical devices during the product lifecycle and the associated Quality System.
3. Work on assigned projects as the QA representative to support the business to ensure the design control process, activities, risk management process and design history files (DHF) are in compliance with internal QMS and regulatory requirements.
− Proactively engage with all stakeholders involved with product quality and design transfer.
− Responsible for process validation activities incl. tool validation for medical devices. Able to coordinate for tool validation activities with suppliers.
− Provide direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments and nonconforming material reports.
− Coordinate and oversight the change control process to ensure the process and records are appropriate and accurate.
− Handle product complaint/inquiry requests or investigations in accordance to client or regulator’s requirements.
4. Owns and maintain Quality Key Performance Indicators (KPIs) for area of expertise.
5. Other duties as assigned.
負責有害物質管理系統,包括定期更新醫療器材適用之法規標準,具備針對新制定或更新之法規與標準之風險分析與影響評估,蒐集供應商端的符合性宣告/報告/或相當證據證明符合性,建立與維持有害物質資料庫。
負責確校活動審查,例如模具/製程確校,輔導與教育外包供應商,符合內部規範。
負責相關事務之異常偏差、矯正行動與風險評估等。支援所指配專案的品質活動或其他臨時指派事項。
1.工廠內部跨部門整合與客戶間溝通窗口,負責新產品導入及跨組織整合,量產後Yield rate提升,return rate降低
Be an integrator of internal cross-functional departments in factory and a communication window for customer.
Responsible for new product introduction phase in and integrating cross-organizationally.
Increase yield rate and reduce return rate after mass production.
2.屬工廠方面的國內外客戶參訪的安排,簡報製作以及接待
Arrange the factory tour for local and foreign customers and make presentation report related to factory tour.
3.屬工廠方面的客訴問題處理以及矯正預防措施回覆
Deal with the customer complaint issue related to factory duty and reply corrective action.
4.工廠生產品質問題處理以及相關會議召開
Host the meeting to deal with manufacturing quality issue.