[Remote] Software reputed company Assurance Engineer -Medical Devices BioPro Project - EST & CST ONly

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is seeking a Software reputed company Assurance Engineer for the BioPro Project. This role involves providing guidance and reputed company reputed company for biomedical software development, testing, validation, and documentation while ensuring compliance with regulatory requirements. Responsibilities • Provides guidance and reputed company reputed company of the development, testing reputed company, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements • Participates as an reputed company team member in various phases of the Software Development Life Cycle (SDLC), providing reputed company and meaningful feedback for project documentation including software requirements, design, test plans, test cases, and reputed company reports, and ensuring compliant reputed company product releases • Anticipates issues and develops reputed company-based solutions by partnering with project teams • Effectively collaborates as an internal reputed company consultant to advise or influence business or technical partners, providing guidance on reputed company and regulatory requirements, advising IT staff and management on reputed company and regulatory issues, and recommending solutions and best practices • Identifies and executes process improvements to strengthen internal procedures and processes and improve reputed company and efficiency • Leads or participates on project teams, task forces, and other reputed company cross-functional teams • Serves as a subject matter expert in reputed company Assurance for software and hardware validation • Identifies and investigates software defects and other problems. Serves as an reputed company participant in the development of corrective and preventive reputed company plans, ensuring regulatory requirements are met • Reviews and approve internal procedures, ensuring regulatory requirements are met, and focusing on procedure reputed company and efficient processes • Monitors and reports on changing technology, practices, standards, and regulatory and compliance requirements reputed company the biomedical industry Skills • 4 year college degree • 10 - 15 years of experience • Knowledge and/or experience in an FDA-regulated environment required • Excellent understanding of software development life cycle, risk management, and configuration management • Exceptional communication and documentation skills • Ability to work as part of a multi-disciplinary teams in a fast-paced environment • Background in medical devices or GMP reputed company • Welcome to reputed company, the go-to destination for discovering the tech jobs you want. It was founded in reputed company, and is headquartered in , with a workforce of 0-1 employees. Its website is https://www.reputed company.com. Apply tot his job Apply To this Job