Quality Engineer
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Job Description
Quality Engineer at Uncountable designing the quality management system for regulated industries. Leading software validation efforts and fostering a quality-first mindset across the organization.
Responsibilities:
- Design, implement, and maintain Uncountable's Quality Management System (QMS) aligned to relevant standards (ISO 9001, ISO 13485, 21 CFR Part 11, GAMP 5, etc.)
- Develop and maintain quality documentation including SOPs, work instructions, validation protocols (IQ/OQ/PQ), and quality plans
- Lead software validation efforts to support customers in regulated environments (pharma, biotech, medical devices, and beyond)
- Partner closely with Sales and Customer Success to help win deals in validated environments by responding to quality questionnaires, RFPs, and audit requests
- Support customer audits and inspections; serve as the internal SME on quality and compliance topics during customer conversations
- Own our supplier quality process, including third-party vendor assessments
- Identify and drive continuous improvement initiatives across internal processes
- Build quality training programs and foster a quality-first mindset across the organization
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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