Ph3Job Description /h3 pPOSITION SUMMARYbr/Location: Mirandola, Italy.br/The bQuality Site Lead /b will play a pivotal role in establishing and executing the Quality Management System (QMS) at a new medical device RD disposables and pilot manufacturing site. This individual will serve as the on‑site quality authority and primary liaison between corporate quality leadership and site operations, ensuring that all activities align with global QMS standards, regulatory requirements, and business objectives. br/This role requires a broad and deep understanding of medical device quality systems, exceptional attention to detail, and the ability to drive hands‑on implementation in a fast‑paced environment. The ideal candidate will combine strategic insight with operational execution to build a compliant, efficient, and audit‑ready site. /p h3Responsibilities /h3 h3Quality System Implementation Oversight /h3 ul liLead the deployment of the company’s established QMS at the new site, ensuring full compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulatory standards. /li liTranslate corporate quality policies and procedures into site‑level processes, documentation, and training where appropriate. /li liDevelop, implement, and maintain quality procedures specific to site operations (e.g., incoming inspection, manufacturing quality controls, calibration, document control, CAPA, and supplier management). /li liSupport site RD Team on the tasks related to Quality and act as point of reference between the RD team and Quality Team in Andover, MA., USA. /li /ul h3Site Readiness Launch Execution /h3 ul liServe as the quality lead for all site startup activities, including facility qualification, utilities qualification, environmental monitoring setup, and equipment installation, validation and maintenance. /li liPartner with Engineering, Manufacturing, and Operations teams to ensure quality requirements are incorporated into all aspects of site design and readiness. /li liSupport process transfer and validation (IQ/OQ/PQ) activities to ensure readiness for commercial manufacturing. /li liParticipate in qualification of cleanrooms, critical systems, and production equipment, ensuring documentation meets regulatory and QMS requirements. /li liEstablish systems for incoming material inspection, in‑process controls, and final release to ensure consistent product quality. /li liDrive readiness for regulatory and customer audits by ensuring all quality documentation, records, and processes are audit‑ready prior to site activation. /li /ul h3Operational Quality Leadership /h3 ul liServe as the site’s quality authority, providing guidance and decisions on nonconformances, deviations, and corrective/preventive actions. /li liManage document control and recordkeeping in accordance with corporate QMS and regulatory expectations. /li liConduct internal audits and support external inspections or audits as the site’s primary quality contact. /li liMonitor and report site quality performance metrics; drive continuous improvement initiatives. /li /ul h3Collaboration Communication /h3 ul liWork closely with corporate Quality, Regulatory, and Operations teams to ensure seamless alignment and compliance across sites. /li liTrain and mentor site personnel on quality requirements and best practices. /li liServe as the quality liaison to leadership, representing site progress, risks, and key milestones. /li /ul h3Management Responsibilities /h3 ul liInitially, this position will not have management responsibilities. /li /ul h3Physical Attributes /h3 ul liAbility to lift up to 30 pounds unassisted. /li liOffice environment. /li liTravel up to 10% throughout Europe. Occasional travel to the US for training, maybe once a year. /li /ul h3Minimum Qualifications /h3 ul liBachelor’s degree in Engineering, Life Sciences, or related technical field. /li li7+ years of experience in Quality Assurance or Quality Systems within the medical device or regulated life sciences industry. /li /ul h3Preferred Qualifications /h3 ul liExperience with new site setup, design transfer, or manufacturing scale‑up. /li liStrong working knowledge of FDA 21 CFR 820, ISO 13485, and risk management principles (ISO 14971). /li liProven experience implementing or maintaining a QMS in a manufacturing environment. /li liDemonstrated ability to manage multiple priorities and work independently in a startup or site‑establishment setting. /li liExcellent communication, organization, and problem‑solving skills. /li liMust be results‑driven and exhibit a sense of urgency. /li liASQ certification (CQE, CQA, or similar) or equivalent. /li liExperience supporting regulatory inspections or third‑party audits. /li liWorking knowledge of ISO 9001, MDR, or MDSAP environments. /li liComputer knowledge and experience with Microsoft Office. /li /ul pbEvery Organ Wasted is a Life Not Saved. /b /p pTransMedics, Inc. is a commercial‑stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. /p pTransMedics 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. /p /p #J-18808-Ljbffr