Device Quality Engineer

Posted on Nov 14, 2018 by Affinity Executive Search

Massachusetts, MA
Research & Development
Immediate Start
Annual Salary
Full-Time
Device Quality Engineer for software devices to help coordinate resources and activities for the Quality function supporting commercial software applications classified as medical devices including, but not limited to, supporting all phases of in-house and/or outsourced design and development as well as product support processes.Represent Quality function as designee on the cross-functional Global Development Team (GDT)where strategy includes development of commercial software devices supporting the pharmaceutical portfolio.Manage quality activities as the manufacturer of in-house and outsourced developed software application medical devices (software devices) by ensuring, through allocation of resources, quality and regulatory standards are met for the following responsibilities: Provide Quality support for the change control process for software devices. Provide Quality support for the Design History File (DHF) for 510k and other regulatory submissions relating to software devices. Provide Quality support for the design and development process, including risk management according to ISO 14971 requirements, for software devices. Provide training relating to software devices is defined for the design and development and product support teams. Ensure suppliers for software devices are appropriately qualified and documented per procedures. Provide Quality support for the documentation process relating to software devices. Provide Quality support for the complaint/CAPA/MDR/FCA processes relating to software devices. Provide Quality support for ISO 13485 certification, Regulatory Audits, and Regulatory filings for software application devices and/or combination products.

Reference: 569324444

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