RefleXion Medical
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The Senior NPI Engineer leads the engineering efforts in developing and commercializing complex electromechanical radiation therapy devices, focusing on establishing production processes, ensuring quality, facilitating design transfer, and troubleshooting system failures. This role requires collaboration with design engineers and the ability to manage documentation and process validation effectively.
The Manager of Quality Compliance leads post-market surveillance activities and manages QMS programs, including complaints, CAPA, and audits. Responsibilities include investigating product malfunctions, reporting metrics, and ensuring compliance with regulations such as 21 CFR and EU-MDR. This role also involves cross-functional collaboration and contributes to quality training and process improvements.