Sr. Specialist Quality Assurance

Abbott

Alameda, California, United States
Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Not specified
5 years software quality assurance experience
Knowledge of fda qsr and iso guidelines
Experience with agile methodologies
Abbott is seeking a Sr. Specialist in Quality Assurance to join their Diabetes Care team in Alameda, California. The role focuses on ensuring compliance with software quality standards in the development and maintenance of medical devices, while also offering a supportive work environment with significant benefits

Job Summary

  • The role involves ensuring systems and applications are developed, validated, and maintained in compliance with regulatory requirements for Abbott Diabetes Care.
  • Employees receive free medical coverage via the Health Investment Plan (HIP) PPO, an excellent retirement savings plan, and tuition reimbursement benefits.
  • The position requires reviewing deliverables such as System Specifications, Verification Test Cases, and Trace Matrices within the ADC Design Control Process.

Matching Summary

Match Score: 85

Abbott is seeking a Sr. Specialist in Quality Assurance to join their Diabetes Care team in Alameda, California. The role focuses on ensuring compliance with software quality standards in the development and maintenance of medical devices, while also offering a supportive work environment with significant benefits.

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
  • Review of verification validation protocols
  • Compliance with 21 CFR Part 11

Nice-to-have

  • Medical Device and AI experience preferred
  • Cybersecurity or cloud computing experience
  • ASQ Certifications a plus
  • Mobile applications development knowledge
  • Project management across software lifecycle

Key Requirements

  • Bachelor's degree in scientific, technical, or engineering discipline
  • Minimum 5 years experience in Software Quality Assurance
  • 2-5 years project experience across software lifecycle
  • Knowledge of Design Control requirements
  • Excellent oral and written communication skills

Work Rights

Not specified

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