Director, R&D Quality Assurance
Core
Lead strategic quality assurance governance for surgical ophthalmic devices, ensuring compliant product development, regulatory submissions, and lifecycle management.
Role type
Director, R&D Quality Assurance (Strategic Leadership)
Builds
Surgical ophthalmic devices and related medical technologies
Domain
Medical Devices / Ophthalmic Surgery / Regulatory Compliance
Required skills
Strategic quality governance, Risk management (ISO 14971), Design controls (21 CFR 820), Process capability (CPK/Ppk), Statistical process control (SPC), FMEA (DFMEA/PFMEA), Regulatory submissions, Cross-functional leadership, Data-driven decision making
Preferred skills
Ophthalmic surgical instrumentation, Laser technology, Healthcare/Medical device industry experience
Technologies
ISO 13485, FDA Design Controls, Quality management systems
Responsibilities
Lead strategic product development quality reviews and stage-gate governance, Manage end-to-end Quality Governance process and SLAs, Monitor governance performance and implement continuous improvements, Conduct strategic quality reviews analyzing risk impact, Support enhanced quality monitoring via dashboards and reporting, Collaborate with global teams to advance compliance initiatives
Seniority
Director, Strategic Leadership