Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Hybrid
Fda qsr knowledge
Iso 13485 compliance
21 cfr part 11 expertise
Abbott is seeking a Software Compliance Engineer to join their Diabetes Care division in Alameda, CA. The role involves ensuring compliance of software systems with regulatory requirements while participating in Agile development processes
Job Summary
This position ensures digital applications and firmware are developed and maintained in compliance with regulatory and corporate requirements.
The role involves reviewing change plans, test reports, and defect management processes within an Agile software development environment.
Employees qualify for free medical coverage, a high employer contribution retirement plan, and tuition reimbursement benefits.
Matching Summary
Match Score: 85
Abbott is seeking a Software Compliance Engineer to join their Diabetes Care division in Alameda, CA. The role involves ensuring compliance of software systems with regulatory requirements while participating in Agile development processes.
Salary
Base: $90,000.00 – $180,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
FDA QSR knowledge
ISO 13485 compliance
21 CFR Part 11 expertise
Design Control requirements
Agile software testing
Medical device experience
Nice-to-have
ASQ Certification
Cybersecurity knowledge
Cloud computing experience
Mobile application testing
Excellent communication skills
Key Requirements
Bachelor's degree in scientific or engineering discipline
2 to 5 years Software Quality Assurance experience
1 to 3 years project experience in software testing