Euclid Systems Corporation is global leader in myopia management solutions, specializing the manufacture of custom-made rigid gas permeable contact lenses for orthokeratology, a Class III medical device. We are seeking a highly-motivated Director/VP of Quality Assurance & Regulatory Compliance to join our fast-growing team. The incumbent will be a member of Euclid’s Executive Team reporting to the President and CEO, and will be responsible for the leadership, management, and oversight of all aspects of Quality Assurance and Regulatory Compliance within the company and will oversee clinical and product registration activities.
Maintain and improve Euclid’s Quality Management System to ensure compliance with worldwide medical device regulations and standards (FDA, CFDA, MDD, etc.), and to improve operational effectiveness
Serve as the subject matter expert on applicable health agency regulations and industry best practices, and provide technical and regulatory guidance regarding global regulations to internal and external stakeholders to ensure overall quality and compliance.
Maintain and improve a compliant and effective risk-based product and process lifecycle validation program including design controls, risk management, design and process verification and validation, change control, and continuous process monitoring
Manage product & patient risk to ensure effective management and control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise
Develop and implement a pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease inefficiencies and improve risk management
Ensure all corporate sites maintain continued certification to all regulatory bodies, playing a lead role in all internal and external audit programs including corporate, notified bodies, and regulatory agencies (FDA, CFDA, ISO, etc.)
Ensure regulatory compliance of clinical activities to demonstrate safety and efficacy of Euclid materials and devices, and lead global product registration activities
Additional Salary Information: Salary negociable based on experience