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Software Quality Assurance Engineer

Warman O'Brien
Alameda, CA Full Time
POSTED ON 2/14/2025
AVAILABLE BEFORE 5/11/2025

Software Quality Assurance consultant

Diagnostics / Medical Device / Pharmaceutical

Contract details :

  • 12-month freelance contract
  • Onsite in Alameda, California
  • 40 hours / week, competitive hourly rate
  • Global Engineering Consulting firm

Overview :

Seeking an experienced SQA professional to ensure compliance and quality of SDLC deliverables for regulated IT applications.

Responsibilities :

  • Review / approve SDLC deliverables : MVP testing, FMEA, IQ, OQ, PQ, trace matrices, system releases.
  • Provide validation expertise for IT applications and ensure compliance readiness.
  • Collaborate with development teams to align deliverables with business and compliance standards.
  • Oversee CAPAs, change controls, and defect management.

    • Qualifications :

  • 5 years in software validation and QA.
  • Direct experience in medical devices / diagnostics preferred - open to pharmaceutical experience
  • Proficient in GxP regulations, validation principles, and automated testing.
  • Experience with Salesforce, Veeva, and tools like JIRA, Tosca, ALM, and Confluence.
  • Knowledge of Agile and Waterfall methodologies.

    • Please apply direct or share a copy of your resume to Brook@warmanobrien.com

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