Quality Engineer

About Uncountable

Uncountable is a leading R&D software platform that helps scientists and engineers in industries like materials science, specialty chemicals, coatings, and life sciences accelerate product development. We turn experimental data into actionable insights and help teams formulate better products, faster.

As we expand into highly regulated industries, we are building out our quality infrastructure to support customers operating in GxP, ISO 13485, 21 CFR Part 11, and other validated environments.

The Opportunity

You will be the first dedicated Quality Engineer at Uncountable. You will own the design and implementation of our quality management system (QMS), shape our internal quality culture, and play a direct role in enabling sales to regulated industries by ensuring our platform meets the standards that enterprise customers require.

You will have real ownership, real accountability, and a direct line to leadership. If you thrive on building things from scratch, navigating ambiguity, and seeing your work translate into closed deals and happy customers, this is the role for you.

Currently, we do not sponsor employment visas for this position. Applicants must be legally authorized to work in the US without current or future sponsorship.

What You'll Own

• 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

What We're Looking For

Required:

• 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)

• Strong written and verbal communication skills

• Self-starter mentality: you're comfortable building processes where none exist and making decisions with incomplete information

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