Nanobiosym is seeking a Software Quality Assurance Engineer. This candidate will be tasked with owning the documentation generation of software requirement specs, software specifications, verification testing protocols, documentation, and other deliverables required by our established quality management system. This role will be supporting the commercialization of our pipeline of products and will be in conformance with FDA Regulations (21 CFR 820), ISO 13485, ISO 14971, and cGMP documentation.
Responsibilities include the following:
* Identify and author the software requirement specification and own the software development plan. * Generate test protocols that verify the software meets the requirements * Contribute to the DVTP (design verification test plan) and software traceability matrix. * Review existing software code and create QMS documents. * Contribute to change documentation, Design History File (DHF), and Device History Records (DHR/Batch Records), Device Master Record (DMR), and configuration management plan. * Facilitate timely review of mission critical documentation and reviewing document drafts for format, clarity, grammar and spelling. * Engage in activity necessary to foster success for Nanobiosym's Quality Assurance and Regulatory Affairs functions in a cross-functional collaborative manner.