Uncountable Inc.

Quality Engineer

Uncountable Inc.

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $100,000 - $120,000 per year

About the role

  • 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

Requirements

  • 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)
Benefits
  • health insurance
  • flexible work arrangements
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality management systemquality documentationSOPsvalidation protocolscomputer system validationsoftware validationcontinuous improvementquality training programs
Soft Skills
leadershipcollaborationcommunicationproblem-solving
Certifications
ISO 9001ISO 1348521 CFR Part 11GAMP 5