This position is responsible to support the Product Development Director’s efforts to complete the overall Product Development activities, including project and program management of new RapidPulse products. This position is responsible for generating required documentation for the RapidPulse Design History File. This position is responsible for developing and maintaining the overall RapidPulse Design Control requirements, with particular attention to Design History File development and maintenance, including deliverables required of the critical suppliers.
This position is responsible for establishing, developing, and managing the overall RapidPulse electronic Quality Management System (QMS), with particular attention to the early development phases, including Risk Management activities and Design Controls. Responsible for establishing a quality system that promotes customer satisfaction and that positively impacts the financial performance of RapidPulse. Champion continuous improvement efforts and implement quality projects to raise the performance of the company's product lines. The position is responsible for overseeing critical supplier quality activities and ensuring controls are in place to qualify and validate those products effectively. The role will ensure initial clinical builds of system components are conducted within design control requirements, including overseeing Receiving Inspection activities and other Quality Control activities through final release.
This position is responsible for supporting the Clinical & Regulatory Affairs VP’s efforts to conduct various worldwide clinical evaluations of the RapidPulse products and to collect Physician feedback during these studies. This information would then be summarized and shared with the development team to direct the overall product design process. The role will require significant worldwide travel with the opportunity to interact in a hospital setting directly with physicians.
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