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TransMedics, Inc. • Andover, MA 05544 • Posted 1 day ago via LinkedIn
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The Design Quality Manager at TransMedics, Inc. is responsible for overseeing the Design Quality process to ensure compliance with internal design control procedures, FDA, ISO, and other applicable requirements. This role involves acting as a subject matter expert on design control and risk management processes, leading risk management activities, providing guidance to stakeholders, and managing the Design Quality Engineer(s) team. The position also supports the quality management system and internal/external audits.
Participate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize technical training and compliance experience to ensure that company design control projects comply with internal design control procedures in accordance with FDA and ISO requirements.
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
REQUIREMENTS:
EDUCATION:
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