DET QARA - (Sr.) Quality System Engineer (QMS)

【About Us】
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 United States.

【Job Overview】
Establish and maintain end-to-end quality management system for active medical device in emergent technologies and digital health industries.

【Main Responsibilities】

• Develop and implement a QMS that meets the needs of the organization and its customers
• Expand Design focus QMS to fully functional Legal Manufacturer QMS
• Active medical device end-to-end QMS accountability 
• Monitor and audit QMS expansion to ensure effective at different transition phases
• Identify and address any nonconformities to ensure effective closures
• Manage corrective and preventive actions
• Provide training on QMS requirements to employees
• Establish supplier quality management process
• Support the organization's continuous improvement efforts

【Required Skills & Qualifications】

• Bachelor's degree in quality management, engineering, business or a related field
• 5+ years of experience in quality management
• Strong understanding of QMS principles and practices
• Experience with relevant standards such as ISO 13485, EU MDR and US FDA CFR, etc.
• Excellent communication and interpersonal skills
• Result oriented, Team player, pragmatic & pro-active
• Ability to work independently and as part of a team
• English listening/speaking/reading/writing

• 提供完善的薪資及福利制度(含三節、年終、績效獎金與員工酬勞等) Comprehensive salary and benefits
• 年度員工健康檢查 Annual health check program
• 員工團體保險(含意外險、防癌險、醫療險) Group insurance program
• 優於勞基法特休天數 Better package in annual leave with pay
• 彈性工作時間 Flexible working hours
• 生育、婚喪補助金、旅遊津貼 Subsidies of travel, birth, marriage and funeral grants etc.
• 教育訓練(新進同仁訓練、OJT訓練、證照訓練、語文訓練、管理訓練等) Training programs (New employee orientation, OJT, licensing, language and management training etc.)
• 多元開放的工作環境 Diverse and open working environment