Sr. Analyst, Quality Systems working under the direction of Sr. Manager, Quality Systems will help in development and implementation of Edwards TMVR Quality System. The main areas of responsibility include, but are not limited to effective development and implementation of Edwards TMVR Quality Systems which includes labeling processes, TMVR training processes, TMVR Document Control system, and maintenance of TMVR specific external regulatory standards, regulatory audits etc.
Supports implementation of compliant and effective Edwards TMVR Document Control system.
Provides support with DCO process (processing of DCO/ECR/ECN).
Supports development and implementation of Edwards TMVR labeling processes.
Supports development and implementation of Edwards TMVR training program and LMS implementation (training plan development, assignment, tracking and reporting)
Responsible for TMVR external regulatory standards management process.
Interfaces with Manufacturing Operations, Engineering, Quality, Supply Chain, and other departments to resolve issues, and support key milestones for TMVR product labeling and TMVR training process.
Creates regular reports on metrics as requested by management. Identifies opportunities for process improvement.
Assists with Quality Management Review presentations.
Lead and assist in CAPA investigation
Participate in external regulatory inspection activities. Assist in facilitating TMVR internal audits.
Performs other tasks, responsibilities as assigned.
Required Education and Skills:
A bachelor’s degree in quality, science, engineering, or related field is preferred. A combination of education, certification, and quality experience may be considered a substitute for a bachelor’s degree.
A minimum of five (5) years of quality experience in a medical device company is strongly preferred. Will consider other highly regulated industries.
Proficient understanding of quality systems, document control, training processes, labeling processes and medical device regulations.
Strong verbal/written communication and organization skills along with good judgement skills within generally defined policies and practices.
Ability to work independently with little or no supervision.
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in No...rth America, Europe, Japan, Latin America and Asia and currently employs about 7,000 individuals worldwide.
For us, helping patients is not a slogan – it's our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we help ensure that patients regain and even improve their quality of life.
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