The Unified Laboratory Informatics & Data Management Platform for Modern R&D Organizations
Quality Engineer
Location
United States
Posted
15 days ago
Salary
$100K - $120K / year
Job Description
Job Requirements
- 2+ years of experience in a quality engineering, quality assurance, or compliance role — ideally in a software, SaaS, or software-as-a-medical-device (SaMD) environment
- Hands-on experience with regulated industries such as pharmaceuticals, biotech, medical devices, or specialty chemicals
- Familiarity with 21 CFR Part 11, GAMP 5, ISO 9001, or ISO 13485 standards and their practical application
- Experience writing and executing computer system validation (CSV) or software validation documentation (IQ, OQ, PQ protocols)
Benefits
- health insurance
- flexible work arrangements
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