【Det Qara】 Senior Quality System Engineer (Qms)

【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