Quality Engineer

Remote (United States)

Employment Type

Full-Time

Department

Engineering

Compensation

$100,000 - $120,000 per year

Overview

This opportunity is for a Quality Engineer to build and scale a quality foundation for a software platform used in regulated environments. The role focuses on designing and implementing a Quality Management System (QMS), leading software validation practices, and enabling customer requirements for standards such as GxP, ISO 13485, 21 CFR Part 11, and other validated frameworks.

A successful candidate is comfortable creating structure from scratch, collaborating across teams, and supporting customer compliance needs through audits, documentation, and continuous improvement.

What You’ll Do

• Design, implement, and maintain a Quality Management System (QMS) aligned to relevant standards (ISO 9001, ISO 13485, 21 CFR Part 11, GAMP 5, and similar frameworks).
• Create and maintain quality documentation, including SOPs, work instructions, quality plans, and validation protocols (IQ/OQ/PQ).
• Lead computer system validation (CSV) and software validation efforts for customers operating in regulated environments (pharma, biotech, medical devices, and related industries).
• Partner with Sales and Customer Success to support regulated customers by completing quality questionnaires, responding to RFPs, and addressing audit requests.
• Support customer audits and inspections and serve as an internal subject matter expert on quality and compliance topics during customer discussions.
• Own supplier quality activities, including third-party vendor assessments and ongoing oversight.
• Identify gaps and drive continuous improvement initiatives across internal processes and controls.
• Build quality training programs and help promote a quality-first mindset across the organization.

Qualifications

• 2+ years of experience in quality engineering, quality assurance, or compliance, ideally within software, SaaS, or software-as-a-medical-device (SaMD).
• Hands-on experience supporting regulated industries such as pharmaceuticals, biotech, medical devices, or specialty chemicals.
• Working knowledge of 21 CFR Part 11, GAMP 5, ISO 9001, and/or ISO 13485, including practical application in day-to-day quality work.
• Experience writing and executing validation documentation, including IQ/OQ/PQ and related CSV artifacts.
• Strong written and verbal communication skills, with the ability to explain quality concepts clearly to both technical and non-technical partners.
• Self-starter mindset and comfort building processes and making decisions in ambiguous, fast-moving environments.

Nice to Have

• Experience in a startup or fast-moving SaaS environment.
• Experience supporting pre-sales or solution engineering activities for regulated customers.
• Familiarity with electronic lab notebook (ELN) tools or R&D platforms.
• Background in materials science, chemistry, or life sciences.