Base: $90,000.00 – $180,000.00; bonus/equity: not ...
5 years software quality assurance experience
Knowledge of fda qsr and iso guidelines
Experience with agile methodologies
This role involves ensuring medical device software systems are developed and validated in compliance with regulatory and corporate requirements
Job Summary
This role involves ensuring medical device software systems are developed and validated in compliance with regulatory and corporate requirements.
The position offers comprehensive benefits including free medical coverage, a high employer contribution retirement plan, and tuition reimbursement.
Candidates will work independently on the Non-Product Software Quality Assurance team within Abbott Diabetes Care to support quality system documentation.
Matching Summary
This role involves ensuring medical device software systems are developed and validated in compliance with regulatory and corporate requirements.
Salary
Base: $90,000.00 – $180,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings, tuition reimbursement
Skills & Requirements
Must-have
5 years Software Quality Assurance experience
Knowledge of FDA QSR and ISO guidelines
Experience with Agile methodologies
Design Control requirements knowledge
21 CFR Part 11 compliance expertise
Nice-to-have
Medical Device and AI experience preferred
Cybersecurity or cloud computing background
Mobile application development experience
ASQ Certification
Project management across software lifecycle
Key Requirements
Bachelor's degree in scientific or engineering discipline
Minimum 5 years in Software QA and Testing
2-5 years project experience in software lifecycle
Familiarity with ISO 13485 and ISO 14971 standards