Quality Site Lead-(Mirandola, Italy)

Job Description:

POSITION SUMMARY

Location: Mirandola, Italy

The Quality Site Lead will play a pivotal role in establishing and executing the Quality Management System (QMS) at a new medical device R&D 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.

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.

RESPONSIBILITIES

Quality System Implementation & Oversight

• Lead 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.
• Translate corporate quality policies and procedures into site-level processes, documentation, and training where appropriate.
• Develop, implement, and maintain quality procedures specific to site operations (e.g., incoming inspection, manufacturing quality controls, calibration, document control, CAPA, and supplier management).
• Support site R&D Team on the tasks related to Quality and act as point of reference between the R&D team and Quality Team in Andover, MA., USA.

Site Readiness & Launch Execution

• Serve as the quality lead for all site startup activities, including facility qualification, utilities qualification, environmental monitoring setup, and equipment installation, validation and maintenance.
• Partner with Engineering, Manufacturing, and Operations teams to ensure quality requirements are incorporated into all aspects of site design and readiness.
• Support process transfer and validation (IQ/OQ/PQ) activities to ensure readiness for commercial manufacturing.
• Participate in qualification of cleanrooms, critical systems, and production equipment, ensuring documentation meets regulatory and QMS requirements.
• Establish systems for incoming material inspection, in-process controls, and final release to ensure consistent product quality.
• Drive readiness for regulatory and customer audits by ensuring all quality documentation, records, and processes are audit-ready prior to site activation.

Operational Quality Leadership

• Serve as the site’s quality authority, providing guidance and decisions on nonconformances, deviations, and corrective/preventive actions.
• Manage document control and recordkeeping in accordance with corporate QMS and regulatory expectations.
• Conduct internal audits and support external inspections or audits as the site’s primary quality contact.
• Monitor and report site quality performance metrics; drive continuous improvement initiatives.

Collaboration & Communication

• Work closely with corporate Quality, Regulatory, and Operations teams to ensure seamless alignment and compliance across sites.
• Train and mentor site personnel on quality requirements and best practices.
• Serve as the quality liaison to leadership, representing site progress, risks, and key milestones.

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

• Initially, this position will not have management responsibilities.

PHYSICAL ATTRIBUTES

• Ability to lift up to 30 pounds unassisted
• Office environment
• Travel up to 10% throughout Europe. Occasional travel to the US for training, maybe once a year.

MINIMUM QUALIFICATIONS

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 7+ years of experience in Quality Assurance or Quality Systems within the medical device or regulated life sciences industry.

PREFERRED QUALIFICATIONS

• Experience with new site setup, design transfer, or manufacturing scale-up.
• Strong working knowledge of FDA 21 CFR 820, ISO 13485, and risk management principles (ISO 14971).
• Proven experience implementing or maintaining a QMS in a manufacturing environment.
• Demonstrated ability to manage multiple priorities and work independently in a startup or site-establishment setting.
• Excellent communication, organization, and problem-solving skills.
• Must be results-driven and exhibit a sense of urgency.
• ASQ certification (CQE, CQA, or similar) or equivalent.
• Experience supporting regulatory inspections or third-party audits.
• Working knowledge of ISO 9001, MDR, or MDSAP environments.
• Computer knowledge and experience with Microsoft Office.

Every Organ Wasted is a Life Not Saved.

TransMedics, 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.

www.TransMedics.com

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.