Infojini Inc ยท 1 day ago
Quality Assurance Consultant
United States
Contract
Remote
Senior Level, Lead/Staff
10+ years expInfojini Inc is a company focused on providing quality assurance in the biomedical software sector. The Quality Assurance Consultant will support development, testing, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements while participating in various phases of the System Development Life Cycle (SDLC).
Information Technology
Hiring Manager
Arvind Dhasmana
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
Excellent understanding of risk management
Excellent understanding of 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 is strongly preferred
Company
Infojini Inc
Infojini Inc. delivers innovative IT Services and Solutions to empower startups, Fortune 500 companies, and global enterprises.
501-1000 employees
H1B Sponsorship
Infojini Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (12)
2023 (11)
2022 (5)
2021 (10)
2020 (21)
Funding
Current Stage
Late StageRecent News
Baltimore Business Journal
2023-11-04
Company data provided by crunchbase