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[Medical Devices] Quality & Compliance Senior Engineer

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Job Description


Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day.  Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues. The more than 250 Johnson & Johnson operating companies employ approximately 118,000 men and women in 60 countries and sell products throughout the world.
嬌生集團是全球最具多元性、業務分布範圍最廣的醫療保健用品公司業,我們的產品與服務每天觸及全球近十億生命。我們的足跡遍佈消費品、製藥以及醫療器材與診斷產品市場,提供解決世界主要健康議題的技術與資源。我們在全球60個國家設立250多家營運公司,員工接近12萬人,產品銷售世界各地。
 
The position is designed to be executing overall quality leadership for quality system maintenance, new product launch, and external manufacturer quality activities. To ensure all the local practices are as following in accordance to STD, WWSP, Regional procedures, GMP related standards and local Regulatory requirements.
 
  1. Maintain Local Quality System
  • Review and approve local rework/repacking SOPs and promotional SOPs 
  • Ensure all products related NC and CAPA cases are reported timely
  • New Product Launch Management 
  • Support local new product launch on time on spec - product release preparation (APR) 
  • Control product release in SAP system
  • Conduct product incoming inspection and FAI check before product release
  •  Support to investigate for product quality issues and Initiate product quality incedent to MFG site for quality improvement 
  • Handle and investigate consumer complaints related to quality

      2. Local Supplier Management

  • Prepare quality agreements for approval for local suppliers
  • Support/Lead local aduits including PKG 

Qualifications
see above
Primary Location
Taiwan-Taipei-Taipei-
Organization
Johnson & Johnson Medical Taiwan Ltd. (8582)
Job Function
Quality
Requisition ID
1905793008W