Sr.Design Quality Eng

该职位来源于猎聘 A Day In The Life Of Our Senior Design Quality Engineer - ME/EE Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.

• Review hardware and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy.
• Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management.
• Serves as a technical resource for risk management activities for hardware and systems in compliance with ISO 14971 and IEC 60601.
• Review test plans, and test cases based upon the product and component level requirements ensuring that appropriate statistical techniques are applied.
• Partner with Human Factors SMEs and R&D to assess the usability of a device throughout design and development
• Review and approve V&V system maintenance such as reworks and modification and tracking.
• Review root cause analysis of identified design issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
• Perform audits of Design History Files and support both internal and external audits.
• Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
• Support field service engineering requests and assess serviceability risks.
• Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.
• Work collaboratively and efficiently in a fast-paced environment with minimal supervision and guidance.
• Maintain trained status for and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.
• As the voice of quality, this role will apply and promote best-practice use of statistical tools and techniques throughout the organization.
• Other QMS activities not specified here and as assigned.

About You

• Familiar with FDA, NMPA, EU regulations and international standards related to MD.
• Familiar with ISO13485, ISO9000 and ISO14971, IEC60601 series ... standards.
• Experienced in design development quality, program management process, and better has experienced as system design engineer.
• Disposable hardware experience is necessary, other capital hardware experience is plus.
• Experience with sterilization medical devices including specific standards associated with sterilization is necessary.
• Experienced in leading and supporting internal audit and external audit from 3rd party.
• Familiar with NC/INV/CAPA process, complaint handling process.
• An all-English working environment, good at speaking and writing.
• More than 5 years' working experience in large international medical device enterprises.