Quality Director (Medical Device / USCT)

📋 Description

• Own and evolve the QMS for regulated medical device development, incl. design controls.
• Establish and enforce traceability from user needs to design, verification, and change control.
• Define and run program-level V&V strategy with test plans, protocols, and acceptance criteria.
• Drive risk management (DFMEA/PFMEA, hazards) with mitigations in requirements and verification.
• Lead document control: reviews, approvals, training, retention, and audit readiness.
• Partner with engineering to embed quality in the dev workflow (automated testing, release gates, SCM).

🎯 Requirements

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