Uncountable Inc.

The Unified Laboratory Informatics & Data Management Platform for Modern R&D Organizations

Quality Engineer

QA EngineerQA EngineerFull TimeRemoteTeam 51-200Since 2016Company SiteLinkedIn

Location

United States

Posted

15 days ago

Salary

$100K - $120K / year

Bachelor Degree2 yrs expEnglish

Job Description

• 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

Job 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

Related Categories

Related Job Pages

More QA Engineer Jobs

Senior Director, Quality Assurance – GCP

CultureHQ

Your one-stop shop for collecting, approving, and sharing employee content.

QA Engineer15 days ago
Full TimeRemoteTeam 1-10Since 2017H1B No Sponsor

Senior Director overseeing GCP quality assurance for clinical projects at Cogent Biosciences

Google Cloud Platform
United States
$235K - $275K / year

Senior Quality Engineer

Creyos (formerly Cambridge Brain Sciences)

A simple & scientifically-validated digital platform for assessing cognitive function.

QA Engineer15 days ago
Full TimeRemoteTeam 51-200Since 2002H1B No Sponsor

The Senior Quality Engineer will lead quality initiatives, drive test automation, and ensure high standards throughout the engineering process, collaborating with cross-functional teams and implementing best practices.

AppiumBuildkiteJavaScriptPlaywrightTypeScriptWebdriverio
United States + 30 moreAll locations: United States, Norway, Chile, Italy, Canada, Spain, Hungary, India, France, Latvia, Poland, Serbia, Sweden, Albania, Bulgaria, Portugal, Indonesia, Brazil, Mexico, Uruguay, Colombia, Pakistan, Slovakia, Slovenia, Dominica, Montenegro, Netherlands, Argentina, Ireland, South Africa, Dominican Republic

Senior Mobile QA Engineer

Doximity

The leading digital platform for medical professionals.

QA Engineer15 days ago
Full TimeRemoteTeam 501-1,000Since 2010H1B Sponsor

The Senior Mobile QA Engineer will perform black-box testing for mobile and web applications, create test plans, and improve QA processes, collaborating with various teams to deliver quality software.

Ai/LlmAndroidCharlesiOSProxymanRepeatoSQLWaldo
Indiana + 1 moreAll locations: Indiana, California
$128K - $171K / year
QA Engineer15 days ago
Full TimeRemoteTeam 1-10Since 2016H1B No Sponsor

Quality Assurance Manager leading quality execution in product development at Quince

United States
$150K - $170K / year