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
Nice to Have
- Experience working at a startup or fast-moving SaaS company
- Experience supporting pre-sales or solution engineering for regulated customers
- Familiarity with electronic lab notebook (ELN) software or R&D platforms
- Background in materials science, chemistry, or life sciences
