Location: Remote (U.S. only, excluding Alaska and Hawaii)
Job Type: Full-time
About Us 🔗
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 Affairs 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.
What You'll Do 🔗
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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.
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Build and remediate quality systems — Develop and implement practical policies, SOPs, work instructions, and records aligned with ISO 13485 and FDA quality system requirements.
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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.
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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 History Files (DHF), Device Master Records (DMR), and Device History Records (DHR).
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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.
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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.
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Perform assessments and remediation — Conduct FDA and ISO 13485 gap assessments, prioritize findings, develop remediation plans, and help clients close gaps with appropriate evidence.
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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.
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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.
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Support regulatory work through the QMS — Coordinate with regulatory and engineering colleagues when submission projects require quality-system processes or records, without owning regulatory strategy or submission preparation.
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Mentor quality team members and review work for clarity, consistency, and compliance.
What We're Looking For 🔗
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3+ years of experience in medical device quality assurance or quality systems, including hands-on responsibility for implementing, operating, or remediating a QMS.
- Experience completing at least one FDA inspection.
- Strong working knowledge of ISO 13485 and FDA medical device quality system requirements.
- Demonstrated experience with several core quality processes, such as document control, training, supplier quality, design controls, risk management, CAPA, complaints, internal audits, and management reviews.
- Experience leading an eQMS implementation, QMS migration, or major quality-system improvement project is a benefit.
- Ability to lead client engagements independently, manage multiple workstreams, and communicate effectively with both technical and executive audiences.
- Excellent quality writing—clear, precise, practical, and appropriately documented.
- Strong judgment about how to scale processes to a company's size, product, development stage, and risk profile without sacrificing compliance.
- Experience preparing for or supporting FDA inspections, ISO 13485 certification audits, or MDSAP audits.
- Familiarity with software and Software as a Medical Device (SaMD) development is strongly preferred, including IEC 62304 and ISO 14971. Experience with AI/ML-enabled devices is a plus.
- Comfort learning and configuring software tools. Experience with Notion or another eQMS platform is a plus.
- Consulting experience and a track record of training or mentoring client teams are strongly preferred.
- An ASQ certification, ISO 13485 auditor credential, or advanced degree in a relevant field is a plus but not required.
- Regulatory submission experience is not required; this role is centered on QMS implementation and ongoing quality support.
What We Offer 🔗
- Competitive base salary ($100,000 – $120,000) depending on experience, including depth of medical device QMS implementation, consulting, and eQMS expertise
- 10% performance-based bonus
- Fully remote work with flexible hours
- Comprehensive PTO package
- Partial healthcare reimbursement and automatic 3% contribution to a 401(k) retirement plan
- Vision and dental plan with reimbursement
- Annual company retreat for team building and collaboration
How to Apply 🔗
Please fill out this application form. In the cover letter, briefly explain:
- Why this role interests you
- One QMS or eQMS implementation or remediation engagement you led and the outcome
- How you make a quality system both compliant and practical for the people using it
What Happens Next 🔗
We'll review your application and contact strong matches. The process includes interviews, a short take-home exercise, and two reference checks.
