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Edwards Lifesciences

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Foundation Health Partners

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Massachusetts General Hospital

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Sr. RA/QA Specialist l
AIM OF THE POSITION The Senior QA/RA Specialist I is responsible for supporting the Senior Director of QA/RA in leading the planning, maintenance and improvement of compliance with Quality Management Systems (QMS) processes relevant to Agendia, Inc., which helps ensure compliance with regulatory requirements and standards that are applicable, such as FDA, CAP, CLIA, ISO). The Senior QA/RA Specialist I also ensures timely registrations and renewals, certifications, creation and maintenance of Technical Files, participates in design and risk management activities, and completion of other quality and regulatory work required to maintain worldwide compliance. POSITION WITHIN THE ORGANIZATION Reports to Senior Director QA/RA

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