Quality Engineer

7Seventy; United States; Hybrid; USD 85,000 - 110,000; Full time

Job summary

7Seventy is seeking a Quality Engineer to build and scale a quality foundation for a software platform used in regulated environments. You will design and implement a Quality Management System (QMS), lead software validation, and help customers meet GxP, ISO 13485, and 21 CFR Part 11.

The role involves collaborating across teams, supporting audits, creating documentation, and driving continuous improvement, with a focus on supplier quality and training to foster a quality-first culture.

Qualifications

• 2+ years in quality engineering or quality assurance within software/SaaS or SaMD.
• Experience in regulated industries such as pharma, biotech, medical devices.
• Working knowledge of 21 CFR Part 11, GAMP 5, ISO 9001 and ISO 13485.
• Experience writing and executing validation documentation (IQ/OQ/PQ) and CSV artifacts.
• Strong written and verbal communication; able to explain quality concepts clearly.
• Self-starter mindset; able to build processes in ambiguous, fast-moving environments.

Responsibilities

• Design, implement, and maintain a QMS aligned to ISO standards.
• Create and maintain quality documentation including SOPs and validation protocols.
• Lead CSV and software validation for regulated customers.
• Collaborate with Sales and Customer Success to support audits and RFPs.
• Support customer audits and act as a QM SME in discussions.
• Own supplier quality activities and vendor oversight.
• Identify gaps and drive continuous improvement across processes.
• Build quality training programs and promote a quality-first mindset.

Skills

Quality engineering

Regulatory compliance

Documentation

CSV knowledge

Communication

Process improvement

Tools

ELN tools

R&D platforms

Job description

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.