Quality Assurance Specialist

Quality Assurance Specialist

Location: Remote (U.S. only, excluding Alaska and Hawaii)

Job Type: Full-time

Innolitics is a remote-first medical device consultancy that brings software engineering, AI/ML validation, cybersecurity, regulatory affairs, and quality management together on one team. Since 2012, we've helped 70+ medical devices reach market, including 50+ FDA clearances. Learn how we take devices from concept to clearance .

We're hiring a Quality Assurance Specialist to lead implementations of Medtech OS—our Notion-based quality management system—and provide ongoing quality services to medical device companies, especially teams developing software and AI/ML-enabled devices.

You’ll help clients turn quality requirements into practical, sustainable ways of working. Engagements include building a QMS from the ground up, remediating an existing QMS, implementing Medtech OS, training client teams, and providing ongoing support for day-to-day quality activities.

You may support submission-related projects only where they intersect with the QMS, including design controls, risk management, software lifecycle processes, and audit-ready quality records, but this role is focused on the quality side of things. If you’re interested largely in the regulatory side, please apply to one of our other positions.

This position is fully remote, with 3–4 trips per year, including client or conference travel and our annual company retreat.

• Lead Medtech OS implementations — Assess each client's current state, define the QMS scope, develop an implementation plan, configure the system, coordinate content migration, and guide the team through launch.
• Build and remediate quality systems — Develop and implement practical policies, SOPs, work instructions, and records aligned with ISO 13485 and FDA quality system requirements.
• Implement core QMS processes — Support design and development controls, risk management, cybersecurity, document and change control, training, supplier controls, purchasing, production, distribution, complaints and feedback, CAPA, management review, internal audits, monitoring and measurement, mandatory reporting, recalls, and quality planning.
• Create audit-ready quality records — Help clients establish and maintain quality manuals, roles and responsibilities matrices, training matrices and records, approved supplier lists and qualifications, document change orders, internal audit schedules, Design and Development Files (DDF), Device Master Records (DMR), and Device History Records (DHR).
• Train and enable client teams — Lead working sessions, provide role-based training, answer day-to-day questions, and help clients adopt consistent quality practices rather than treating the QMS as a set of static documents.
• Provide ongoing quality services — Support internal audits, management reviews, design changes, CAPAs, supplier qualifications, complaint handling, reportable-event assessments, post-market activities, and inspection readiness.
• Perform assessments and remediation — Conduct FDA and ISO 13485 gap assessments, prioritize findings, develop remediation plans, and help clients close gaps with appropriate evidence.
• Manage client engagements — Run meetings, set agendas, maintain implementation plans, communicate risks and decisions, and translate quality requirements into clear actions for technical and executive audiences.
• Improve Medtech OS — Capture client and team feedback, identify bugs and workflow gaps, and collaborate with our software and quality teams to improve templates, usability, and implementation methods.
• Support regulatory work through the QMS — Coordinate with regulatory and engineering colleagues when submission projects require quality-system processes or…