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
1. Serve as the quality lead for all site startup activities, including facility qualification, utilities qualification, environmental monitoring setup, and equipment installation, validation and maintenance.
2. Partner with Engineering, Manufacturing, and Operations teams to ensure quality requirements are incorporated into all aspects of site design and readiness.
3. Support process