【DET QARA】Quality Risk Manager/ Sr. Risk Management Quality Engineer

【Job Overview】
This is a Taiwan-based role that will work across the global organization and collaborate with stakeholders, internal/external Subject Matter Experts and Industry Authorities.
The role will drive and facilitate discussions and continuous process improvement related to medical device including SaMD risk management from R&D through manufacturing and the supply chain to post market activities including vulnerability monitoring and incident assessment for drug delivery systems of varying complexity and technologies.
The Risk Manager/ Sr. Risk Management Quality Engineer will be expected to be a thought leader within the domain of medical device risk management, who will manage and maintain the risk management process as well as lead and execute on key projects while consistently showing progress in supporting the development of our Medical Device Quality Engineering core competencies.

【Main Responsibilities】
• Lead and execute key design & development related risk management engineering activities to support new product development — from inception through manufacturing, product launch and scale-up — and on-market products for a broad range of product lines.
• Build and maintain Risk Management Files for assigned device projects and platforms consistent with Customer Requirements and compliant to regulatory requirements, including MDR 2017/745, 21 CFR Part 820, ISO 13485, ISO 11608, IEC60601 and ISO 14971.
• Work with cross-functional teams to ensure product designs meet customer expectations for usability, reliability, safety and effectiveness.
• Establish and maintain consistent requirement, risk management and testing traceability for the timely completion of new product launches and design changes for on-market medical device products.
• Maintain and continuously improve the Risk Management process, supporting practices, tools, methods and procedures.
• Support internal and external regulatory audits and inspections, including third party audits of product design history files and technical files.
• Host Risk Review Board to ensure project risk management practices are aligned with best practices and regulatory requirements.