Quality Site Lead-(Mirandola, Italy)

3 giorni fa

Modena, Italia TransMedics, Inc. A tempo pieno

Job Description Join to apply for the Quality Site Lead-(Mirandola, Italy) role at TransMedics, Inc. Seniority Level Mid-Senior level Employment Type Full‑time Job Function Quality Assurance Industries Medical Equipment Manufacturing 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 & OversightLead 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 ExecutionServe 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

  • Quality Site Lead-(Mirandola, Italy)

    3 giorni fa

    Modena, Italia TransMedics, Inc. A tempo pieno

    Job Description Join to apply for the Quality Site Lead-(Mirandola, Italy) role at TransMedics, Inc. Seniority Level Mid-Senior level Employment Type Full‑time Job Function Quality Assurance Industries Medical Equipment Manufacturing Position Summary Location: Mirandola, Italy The Quality Site Lead will play a pivotal role in establishing and executing the...

  • Quality Site Lead-(Mirandola, Italy)

    3 giorni fa

    Modena, Italia TransMedics, Inc. A tempo pieno

    Job DescriptionJoin to apply for the Quality Site Lead-(Mirandola, Italy) role at TransMedics, Inc.Seniority LevelMid-Senior levelEmployment TypeFull‑timeJob FunctionQuality AssuranceIndustriesMedical Equipment ManufacturingPosition SummaryLocation: Mirandola, ItalyThe Quality Site Lead will play a pivotal role in establishing and executing the Quality...

  • Quality Site Lead-(Mirandola, Italy)

    3 giorni fa

    Modena, Italia TransMedics, Inc. A tempo pieno

    Job Description Join to apply for the Quality Site Lead-(Mirandola, Italy) role at TransMedics, Inc. Seniority Level Mid-Senior level Employment Type Full‑time Job Function Quality Assurance Industries Medical Equipment Manufacturing Position Summary Location: Mirandola, Italy The Quality Site Lead will play a pivotal role in establishing and executing the...

  • Quality Site Lead-(Mirandola, Italy)

    2 giorni fa

    Modena, Italia TransMedics, Inc. A tempo pieno

    Job Description Join to apply for the Quality Site Lead-(Mirandola, Italy) role at TransMedics, Inc. Seniority Level Mid-Senior level Employment Type Full‐time Job Function Quality Assurance Industries Medical Equipment Manufacturing Position Summary Location: Mirandola, Italy The Quality Site Lead will play a pivotal role in establishing and executing the...

  • Quality Site Lead-(Mirandola, Italy)

    4 giorni fa

    Modena, Italia Transmedics, Inc. A tempo pieno

    Job DescriptionJoin to apply for theQuality Site Lead-(Mirandola, Italy)role atTransMedics, Inc.Seniority LevelMid-Senior levelEmployment TypeFull-timeJob FunctionQuality AssuranceIndustriesMedical Equipment ManufacturingPosition SummaryLocation: Mirandola, ItalyTheQuality Site Leadwill play a pivotal role in establishing and executing the Quality Management...

  • Quality Site Lead: Launch

    2 giorni fa

    Modena, Italia TransMedics, Inc. A tempo pieno

    A medical technology company located in Italy is looking for a Quality Site Lead to establish and execute a quality management system at a new medical device R&D site. The ideal candidate will have over 7 years of experience in Quality Assurance within the medical device industry, ensuring compliance with FDA and ISO standards. Responsibilities include...

  • Quality Site Lead: Launch

    3 giorni fa

    Modena, Italia TransMedics, Inc. A tempo pieno

    A medical technology company located in Italy is looking for a Quality Site Lead to establish and execute a quality management system at a new medical device R&D site. The ideal candidate will have over 7 years of experience in Quality Assurance within the medical device industry, ensuring compliance with FDA and ISO standards. Responsibilities include...

  • Quality Site Lead: Launch

    3 giorni fa

    Modena, Italia TransMedics, Inc. A tempo pieno

    A medical technology company located in Italy is looking for a Quality Site Lead to establish and execute a quality management system at a new medical device R&D site. The ideal candidate will have over 7 years of experience in Quality Assurance within the medical device industry, ensuring compliance with FDA and ISO standards. Responsibilities include...

  • Quality Site Lead: Launch

    4 giorni fa

    Modena, Italia Transmedics, Inc. A tempo pieno

    A medical technology company located in Italy is looking for a Quality Site Lead to establish and execute a quality management system at a new medical device R&D site.The ideal candidate will have over 7 years of experience in Quality Assurance within the medical device industry, ensuring compliance with FDA and ISO standards.Responsibilities include leading...

  • R&d Design Quality

    2 settimane fa

    Modena, Italia Capgemini Engineering A tempo pieno

    **Your role**: **R&D Design Quality - Mirandola (Modena)** In Capgemini Engineering, leader mondiale nei servizi di ingegneria, uniamo un team globale di **_ingegner*, scienziat* e architett*_** per aiutare le aziende più innovative del mondo a liberare il loro potenziale. Dai veicoli autonomi ai robot salvavita, **_i nostri talenti_** in tecnologia...