Quality Engineer

Job Summary

As the first dedicated Quality Engineer in a full-time remote role, the successful candidate will design and implement the Quality Management System (QMS), shape the internal quality culture, and support sales efforts in regulated industries by ensuring compliance with necessary standards.

Key responsibilities

• Design, implement, and maintain the Quality Management System (QMS) aligned to relevant standards
• Develop and maintain quality documentation, including SOPs and validation protocols
• Lead software validation efforts and support customer audits and inspections

Required qualifications

• 2+ years of experience in quality engineering, quality assurance, or compliance, preferably in a software or regulated environment
• Hands-on experience with regulated industries such as pharmaceuticals or medical devices
• Familiarity with standards like 21 CFR Part 11, GAMP 5, ISO 9001, or ISO 13485
• Experience writing and executing computer system validation (CSV) documentation
• Self-starter mentality with the ability to build processes and make decisions with incomplete information