Uncountable Inc.

QA Engineer

• 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

Quality Engineer