Uncountable Inc. is hiring its first dedicated Quality Engineer. You will build our quality management system from the ground up, directly support sales to regulated enterprise customers, and shape our internal quality culture.

What You'll Do

Design, implement, and maintain Uncountable's Quality Management System (QMS) aligned to relevant standards
Develop and maintain quality documentation including SOPs, work instructions, and validation protocols
Lead software validation efforts to support customers in regulated environments
Partner closely with Sales and Customer Success to help win deals by responding to quality questionnaires and audit requests
Support customer audits and inspections as the internal subject matter expert
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

What We're Looking For

2+ years of experience in a quality engineering, quality assurance, or compliance role
Hands-on experience with regulated industries such as pharmaceuticals, biotech, or medical devices
Familiarity with standards like 21 CFR Part 11, GAMP 5, ISO 9001, or ISO 13485 and their practical application
Experience writing and executing computer system validation (CSV) or software validation documentation
Strong written and verbal communication skills
Self-starter mentality: you're comfortable building processes where none exist