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Mid LevelFull-time
Salary Range
$102,000 - $138,000 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
We are looking for a Quality Engineer to join Uncountable, a leading R&D software platform that helps scientists and engineers accelerate product development. As the first dedicated Quality Engineer, you will own the design and implementation of our quality management system (QMS) and shape our internal quality culture to support customers in regulated industries.
Key Responsibilities
- →Design, implement, and maintain Uncountable's Quality Management System (QMS) aligned to relevant standards
- →Develop and maintain quality documentation including SOPs, work instructions, validation protocols, and quality plans
- →Lead software validation efforts to support customers in regulated environments
- →Partner with Sales and Customer Success to respond to quality questionnaires, RFPs, and audit requests
- →Support customer audits and inspections as the internal subject matter expert
- →Own supplier quality process, including third-party vendor assessments
- →Identify and drive continuous improvement initiatives
- →Build quality training programs and foster a quality-first mindset
Requirements
- ✓2+ years of experience in quality engineering, quality assurance, or compliance role
- ✓Hands-on experience with regulated industries such as pharmaceuticals, biotech, or medical devices
- ✓Familiarity with 21 CFR Part 11, GAMP 5, ISO 9001, or ISO 13485 standards
- ✓Experience writing and executing computer system validation documentation
- ✓Strong written and verbal communication skills
- ✓Self-starter mentality with ability to build processes from scratch
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