Software Compliance Engineer

Abbott

Alameda, CA, United States
Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Hybrid
Fda qsr knowledge
Iso 13485 guidelines
21 cfr part 11 compliance
Abbott is seeking a Software Compliance Engineer for its Diabetes Care division in Alameda, CA. This role involves ensuring that software applications and firmware meet regulatory requirements while participating in an Agile development environment

Job Summary

  • This position ensures digital applications and firmware are developed and maintained in compliance with regulatory and corporate requirements for Abbott Diabetes Care products.
  • The role involves reviewing change plans, test reports, and defect management processes while actively participating in Agile software development ceremonies.
  • 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 for its Diabetes Care division in Alameda, CA. This role involves ensuring that software applications and firmware meet regulatory requirements while participating in an Agile development environment.

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 guidelines
  • 21 CFR Part 11 compliance
  • Design Control requirements
  • Agile software testing practices

Nice-to-have

  • ASQ Certifications
  • Cybersecurity experience
  • Medical mobile applications
  • Cloud computing experience
  • 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
  • Knowledge of FDA QSR and ISO guidelines
  • Experience with medical devices preferred

Work Rights

Not specified

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