Quality Director (Medical Device / USCT)
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At a glance
Job overview
Midjourney is hiring a Quality Director (Medical Device / USCT). The Quality Director will own and evolve the Quality Management System (QMS) for a regulated medical device development program, including design controls and DHF maintenance. This role involves establishing and enforcing requirements traceability, defining and running the program-level V&V strategy, and driving risk management activities. The director will also lead document control and partner with engineering to integrate quality into the development workflow. Additionally, the director will prepare the program for audits and inspections.
Key focus areas include Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, Establish and enforce requirements traceability: user needs → design requirements → verification/validation artifacts and change control, and Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria.
Successful candidates bring Senior Experience Leading Quality and Deep Familiarity With Design Controls DHF Document Control Risk Management Verification Planning. Important skills include Quality Management System, Design Controls, DHF Maintenance, Requirements Traceability, Verification And Validation Strategy, and Risk Management. Preferred (not required): ISO 13485, 21 CFR 820, Audit Readiness, and FDA-Facing Work.
Skills & qualifications
Skills
Qualifications
Full job description
WHAT YOU’LL DO
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Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, including design controls and DHF maintenance.
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Establish and enforce requirements traceability: user needs → design requirements → verification/validation artifacts and change control.
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Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria.
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Drive risk management activities (e.g., DFMEA / PFMEA, hazard analyses) and ensure mitigations are reflected in requirements and verification.
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Lead document control: reviews, approvals, training, retention, and audit readiness.
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Partner with engineering to make quality “native” to the dev workflow (automated testing, release gates, software configuration management).
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Prepare the program for audits and inspections, including hands-on audit leadership.
WHAT WE’RE LOOKING FOR
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Senior experience leading quality for complex hardware + software products in a regulated environment.
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Deep familiarity with design controls, DHF, document control, risk management, and verification planning.
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Strong systems thinking and the ability to translate ambiguous product intent into testable requirements.
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Comfortable collaborating directly with multidisciplinary engineering (recon/ML, embedded, mechanical, EE, cloud).
USEFUL EXPERIENCE
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Regulated product quality leadership (ISO 13485 / 21 CFR 820 or equivalent), including audit readiness and FDA-facing work.
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eQMS + document control fluency (e.g., Greenlight Guru) that integrates cleanly with modern engineering workflows.
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