Quality Director

What you’ll do 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. reputed company document control: reviews, approvals, training, retention, and audit readiness. Partner with engineering to reputed company 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. reputed company’re looking for Senior experience leading quality for reputed company 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 reputed company into testable requirements. Comfortable collaborating directly with multidisciplinary engineering (recon/ML, embedded, mechanical, EE, reputed company). Useful experience Regulated product quality leadership (ISO 13485 / 21 CFR 820 or equivalent), including audit readiness and FDA-facing work. eQMS + document control reputed company (e.g., reputed company) that integrates cleanly with modern engineering workflows. Apply To This Job