Jobs via Dice · 1 month ago
Software Quality Assurance Engineer -Medical Devices BioPro Project - EST & CST ONly
United States
Full-time
Remote
Senior Level, Lead/Staff
10+ years expAPN Software Services, Inc. is seeking a Software Quality Assurance Engineer for the BioPro Project. This role involves providing guidance and quality oversight for biomedical software development, testing, validation, and documentation while ensuring compliance with regulatory requirements.
Computer Software
Responsibilities
Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements
Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test plans, test cases, and summary reports, and ensuring compliant quality product releases
Anticipates issues and develops consensus-based solutions by partnering with project teams
Effectively collaborates as an internal quality consultant to advise or influence business or technical partners, providing guidance on quality and regulatory requirements, advising IT staff and management on quality and regulatory issues, and recommending solutions and best practices
Identifies and executes process improvements to strengthen internal procedures and processes and improve quality and efficiency
Leads or participates on project teams, task forces, and other complex cross-functional teams
Serves as a subject matter expert in Quality Assurance for software and hardware validation
Identifies and investigates software defects and other problems. Serves as an active participant in the development of corrective and preventive action plans, ensuring regulatory requirements are met
Reviews and approve internal procedures, ensuring regulatory requirements are met, and focusing on procedure clarity and efficient processes
Monitors and reports on changing technology, practices, standards, and regulatory and compliance requirements within the biomedical industry
Qualification
Required
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
Preferred
background in medical devices or GMP
Company
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0-1 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase