Quality Engineer, Regulated Software (QMS & CSV)

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

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.