Sr. Specialist Quality Assurance

Abbott

Alameda, United States
Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Not specified (potentially hybrid or onsite based on the nature of the work)
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 its Non-Product Software Quality Assurance team, focusing on ensuring compliance with quality systems in the development and maintenance of medical device software. The ideal candidate will have extensive experience in software quality assurance, particularly in the medical device sector, and will benefit from Abbott's strong commitment to employee development and well-being

Job Summary

  • Abbott is a global healthcare leader serving people in more than 160 countries with a portfolio of life-changing technologies.
  • The role ensures systems and applications are developed, validated, and maintained in compliance with regulatory and corporate requirements.
  • Employees receive free medical coverage, an excellent retirement savings plan, and tuition reimbursement benefits.

Matching Summary

Match Score: 85

Abbott is seeking a Sr. Specialist in Quality Assurance to join its Non-Product Software Quality Assurance team, focusing on ensuring compliance with quality systems in the development and maintenance of medical device software. The ideal candidate will have extensive experience in software quality assurance, particularly in the medical device sector, and will benefit from Abbott's strong commitment to employee development and well-being.

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 in Software Quality Assurance and Testing
  • 2-5 years project experience across the software lifecycle
  • Knowledge of Design Control requirements
  • Excellent oral and written communication skills

Work Rights

Not specified

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