Principal II, Research & Development Quality Assurance
Core
Leading quality assurance and compliance for R&D functions of surgical ophthalmic medical devices, ensuring adherence to global and local regulations.
Role type
Principal II, Research & Development Quality Assurance
Builds
Surgical ophthalmic medical devices and related processes
Domain
Medical devices / Ophthalmic surgery / Regulatory Compliance
Required skills
Quality engineering support, Design control implementation, Risk management processes, CAPA management, Root cause analysis, Regulatory compliance (FDA/ISO), Technical project management, Resource allocation, Documentation management, SOP adherence
Preferred skills
Certified Quality Engineer (CQE), FDA 21 CFR Part 820 knowledge, ISO 13485 knowledge, ISO 14971 knowledge, Class II/III device development experience, EU MDR familiarity, MDSAP familiarity, ISO 11979 standards knowledge
Technologies
None explicitly stated
Responsibilities
Oversee quality of R&D activities and ensure compliance with quality engineering support, Review implementation of quality system for regulatory adherence, Operate independently to provide oversight of quality and compliance operations, Manage individual technical projects to achieve objectives, Oversee quality assurance processes and support continuous improvement, Lead resolution of deviations and Corrective and Preventive Actions, Ensure compliance of R&D activities and direct personnel execution
Seniority
Principal, hands-on IC with strategic oversight
