About the job
About Uncountable
Uncountable is a pioneering R&D software platform that empowers scientists and engineers in fields such as materials science, specialty chemicals, coatings, and life sciences to expedite product development. By transforming experimental data into actionable insights, we enable teams to formulate superior products more efficiently.
As we grow into highly regulated sectors, we are establishing our quality infrastructure to support clients operating in GxP, ISO 13485, 21 CFR Part 11, and other validated environments.
The Opportunity
We are seeking our first dedicated Quality Engineer at Uncountable. You will lead the design and implementation of our Quality Management System (QMS), cultivate our internal quality culture, and directly contribute to enabling sales in regulated industries by ensuring our platform meets the necessary standards required by enterprise customers.
This role provides you with significant ownership and accountability, along with a direct connection to leadership. If you thrive on building systems from the ground up, navigating uncertainty, and witnessing your contributions translate into successful deals and satisfied customers, this position is perfect for you.
Please note that we do not offer employment visa sponsorship for this position. Applicants must be legally authorized to work in the U.S. without any current or future sponsorship.
What You'll Own
Design, implement, and maintain Uncountable's Quality Management System (QMS) in alignment with 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 clients in regulated environments (pharmaceuticals, biotechnology, medical devices, and more).
Collaborate closely with Sales and Customer Success to secure deals in validated environments by responding to quality questionnaires, RFPs, and audit requests.
Assist with customer audits and inspections; serve as the internal subject matter expert (SME) on quality and compliance topics during customer discussions.
Oversee our supplier quality process, including assessments of third-party vendors.
Identify and lead continuous improvement initiatives across internal processes.
Build quality training programs and foster a quality-first mindset throughout the organization.

