Job Description: ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE: * Provides leadership and guidance to the Quality and Operation team to ensure business, quality and compliance goals are met. * Develop and lead quality assurance, quality engineering and design quality team. Responsible for the application and maintenance of quality standards and the quality management system as they apply to products and services * Develops, maintains and improves quality processes in a rapid growing business environment, to support Class III medical device, in according with 21CFR820, ISO 13485, MDSAP and MDR * Oversee all audits and proactively prepare the organization for inspection readiness * Coordinate quality data collection, analyses and reporting for Management Reviews and Post Market Survellance * Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate * Identifies product and process improvements; leads and supports their implementation * Lead and support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate business growth * Some travel may be required (<5%) * Performs other TransMedics tasks and duties as required EXPERIENCE: * 10 years of proven experience in Quality in the medical device/biotechnology/pharmaceutical industry, or equivalent combination of education and experience * Minimum of 6 years with increasing level of management responsibility * Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations. Experience with MDR a plus. * Strong interpersonal and communication skills * Must possess the ability to handle multiple projects and changing priorities * Must be results-driven and exhibit a sense of urgency * Ability to communicate ideas and information clearly, effectively and concisely * Highly detailed oriented with strong organization and prioritization skills EDUCATION: * BS in Engineering or technical discipline TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.