Base: $98,000.00 – $196,00.00; bonus/equity: not s...
Onsite
6+ years qa or software validation experience
Knowledge of fda qsr and iso13485 standards
Experience with 21 cfr part 11 compliance
Abbott is seeking a Nonproduct SWQA Lead for their Lingo Division in Alameda, California. The role focuses on ensuring compliance in the development and maintenance of computerized systems supporting the Quality System, while offering a dynamic work environment and significant career development opportunities
Job Summary
This role ensures computerized systems supporting the Quality System are developed, validated, and maintained in compliance with regulatory requirements.
The position involves leading validation efforts including Master Validation Plans, Impact Assessments, and Trace Matrices for non-product software.
Abbott offers comprehensive benefits including free medical coverage, high employer retirement contributions, and tuition reimbursement programs.
Matching Summary
Match Score: 85
Abbott is seeking a Nonproduct SWQA Lead for their Lingo Division in Alameda, California. The role focuses on ensuring compliance in the development and maintenance of computerized systems supporting the Quality System, while offering a dynamic work environment and significant career development opportunities.
Salary
Base: $98,000.00 – $196,00.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
6+ years QA or software validation experience
Knowledge of FDA QSR and ISO13485 standards
Experience with 21 CFR Part 11 compliance
Ability to lead validation documentation reviews
Experience coordinating contractor activities
Nice-to-have
Familiarity with Jira, Confluence, or ALM Quality Center
ASQ Certifications preferred
Background in biosensing or wearable technology
Start-up culture mindset within large corporation
Experience with ADC software/firmware products
Key Requirements
Bachelor's Degree in Engineering, Technical Field, or Life Science
6+ years experience in Quality Assurance or software validation