Quality Director – Medical Device, USCT

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Midjourney

WebsiteLinkedInAll Job Openings

11 - 50 employees

🤖 Artificial Intelligence

☁️ SaaS

👥 B2C

Artificial Intelligence • SaaS • B2C

Midjourney is a community-funded research lab of about 60 people that builds generative image (and upcoming video) AI models and related software. The organization is known for creating highly aesthetic AI image models and offers community-driven access (support and product discussions via Discord), documentation, and subscription-style product access; it describes ongoing projects spanning imagination, coordination, reflection, beauty, and human flourishing, and lists future work across image and video models, software, medical and hardware initiatives. Midjourney positions itself as a lean, distributed team focused on amplifying the human spirit through AI-driven creative tools.

📋 Description

• Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, including design controls and DHF maintenance. • Establish and enforce requirements traceability: user needs → design requirements → verification/validation artifacts and change control. • Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria. • Drive risk management activities (e.g., DFMEA / PFMEA, hazard analyses) and ensure mitigations are reflected in requirements and verification. • Lead document control: reviews, approvals, training, retention, and audit readiness. • Partner with engineering to make quality “native” to the dev workflow (automated testing, release gates, software configuration management). • Prepare the program for audits and inspections, including hands-on audit leadership.

🎯 Requirements

• Senior experience leading quality for complex hardware + software products in a regulated environment. • Deep familiarity with design controls, DHF, document control, risk management, and verification planning. • Strong systems thinking and the ability to translate ambiguous product intent into testable requirements. • Comfortable collaborating directly with multidisciplinary engineering (recon/ML, embedded, mechanical, EE, cloud).

🏖️ Benefits

• Health insurance • 401(k) • Paid time off • Professional development opportunities