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