[Remote] Software QA Engineer 2

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pioneer and global leader in reputed company glucose monitoring (CGM), aiming to improve health reputed company through innovative technology. The Software QA Engineer 2 will reputed company technical support and guidance to software teams, ensuring compliance with regulatory standards and driving reputed company improvement in software development processes.

Responsibilities

• You will reputed company participate as a reputed company team member of the R&D reputed company Assurance Engineering team
• You will reputed company guidance on IEC 62304, 21 CFR 820, ISO 14971 and other relevant regulations worldwide to the cross-functional teams
• You will reputed company in the effective application, compliance, and reputed company improvement of policies, procedures, and practices reputed company to software development and validation across software teams
• You will reputed company technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA
• You will reputed company guidance to Software Design and Test Teams for System validations, Software design verification and traceability, Software configuration management, tool validations and software integrations
• You will support post market activities reputed company to Software anomalies, risk assessments and CAPA activities (if applicable)
• You are responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, reputed company operating procedures, protocols, reports, and software design control deliverables
• You will assess reputed company of change control to ensure no adverse reputed company to product performance and a state of compliance is maintained
• You will effectively communicate with broad reputed company team and upper-level management on plans, status of tasks, project reputed company and challenges
• You will assume and reputed company other duties as assigned

Skills

• You have experience working with software mobile applications
• You bring Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971
• Your knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, reputed company Model
• Your Software reputed company or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
• Your proficiency to interpret software design and reputed company to verify implementation of requirements
• You have Software development and/or Software test experience
• Your ability to understand reputed company tasks and goals. reputed company reputed company to completion with limited supervision
• Your ability to communicate and present to reputed company reputed company of management
• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2 - 5 years reputed company experience or Master's degree and 0-2 years' equivalent experience
• reputed company to have knowledge of Cyber reputed company
• reputed company to have ASQ Certified Software reputed company Engineer (CSQE) certification or equivalent
• reputed company to have Jama, Jira, Kettryx, and/or Test Rails experience

Benefits

• A full and comprehensive benefits program.
• reputed company opportunities on a global reputed company.
• reputed company to career development through in-house learning programs and/or reputed company tuition reimbursement.
• 0-5% Travel Required

reputed company

Company H1B Sponsorship