Modular Medical Inc Jobs (1)

Essential Job Functions : Have software quality and quality systems compliance responsibilities for Medical Device Systems Firmware and Medical Device Mobile Applications for Class C Software. Providing technical leadership and software quality engineering support on Medical Device Firmware and Software for Medical Mobile Apps related projects. Providing software quality support and drive validation strategies. Supporting risk management activities to support software product(s). Managing software defects and problem reports. Develop and implement comprehensive software quality assurance strategies, policies, and procedures that ensure compliance with applicable regulations and standards in the medical device industry. Collaborate with cross-functional teams, including manufacturing, engineering, regulatory affairs, and clinical operations, to identify and address quality-related issues and drive continuous improvement. Review Software Specifications / Requirements documents, Review and approve Software Verification Test Plans, Verification Test Cases, Verification / Validation protocols, Trace Matrices and Verification / Validation Summary Reports for Software Testing. Ensure high quality software releases. Support non-product software tool validation assessment, requirements, and verification testing as needed. Lead continuous improvement projects for software device development, production, and quality processes. Ensure that software device quality and regulatory standards are met, including meeting FDA Part 820, ISO 13485, IEC 62304, MDR, and MDSAP requirements as applicable. Assist in developing and maintaining post market activities related to software, i.e. complaint handling, cybersecurity testing, software related quality metric monitoring, etc. Experience and Qualifications : Education : Bachelor's or Master's degree in engineering, science, or a related field. Experience : Minimum of 5 years of experience in a software quality assurance management role in the medical device industry. Proven track record of successful management of quality teams and implementing quality management systems in accordance with applicable regulations and standards. In-depth knowledge of FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), IEC 62304 and other applicable regulations and standards. Experience leading software quality initiatives in collaboration with the product development teams and ensuring that products meet or exceed quality standards and customer expectations. Must be technically strong and have experience testing mobile applications and medical device firmware. Experience supporting FDA, Notified Body, and other regulatory submissions and inspections. Preferred Skills : Software Quality Engineer Certification (CSQE) from ASQ or equivalent Knowledge of FDA’s Cybersecurity Requirements, Testing, and Expectations PI223225917