midjourney - Quality Director (Medical Device / USCT)

Remote - United State1mo ago

Remote Director WW Medical Devices Quality Control Manager Reporting Risk Management EMEA

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). • Regulated product quality leadership (ISO 13485 / 21 CFR 820 or equivalent), including audit readiness and FDA-facing work. • eQMS + document control fluency (e.g., Greenlight Guru) that integrates cleanly with modern engineering workflows.

Responsibilities

• 1. Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, including design controls and DHF maintenance. • 2. Establish and enforce requirements traceability: user needs → design requirements → verification/validation artifacts and change control. • 3. Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria. • 4. Drive risk management activities (e.g., DFMEA / PFMEA, hazard analyses) and ensure mitigations are reflected in requirements and verification. • 5. Lead document control: reviews, approvals, training, retention, and audit readiness. • 6. Partner with engineering to make quality “native” to the dev workflow (automated testing, release gates, software configuration management). • 7. Prepare the program for audits and inspections, including hands-on audit leadership.