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Quality Service Operations

Italy, Rome · Job Posted December 07, 2025
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Job Description

Join the Quality Service Operations team to uphold the highest standards of quality and compliance in post-market support, ensuring exceptional service and reliability for life-saving medical devices.

Job Responsibility

  • Oversee all processes related to the collection and review of the service records
  • Review the service activities related to medical device products and ensure the correctly storage of records
  • Ensure that all service activities comply with regulatory standards, quality control protocols, and company policies
  • Review the service manual and all documentation provided to external parties used to carry out service activities
  • manage the equipment calibration and control the calibration expirations
  • open and manage the non conformities issued during the service process, correction and corrective action
  • manage the complaint activities
  • support the Lead Service Engineer in the implementation of the corrective actions to minimize disruptions
  • ensure that the training and guidance to external parts are correctly registered
  • Support the Regulatory Affairs in the compliance with all relevant regulations, including FDA, ISO, and other international standards
  • Support the Quality Assurance Manager in the service process’s evaluation in compliance with all relevant regulations, including FDA, ISO, and other international standards

Requirements

  • Knowledge of 2017/745(MDR) and 21 CFR 820
  • Knowledge of 13485: 2021
  • Strong technical troubleshooting and problem-solving skills
  • Excellent communication and collaboration abilities
  • Good English Level (writing and speaking)
  • Ability to work independently and collaboratively across multifunctional teams
  • Resilient and able to work effectively under stress and tight deadlines
  • Willingness to travel as needed
  • Minimum of 2 years of experience in the quality assurance role within the medical devices or healthcare industry, with a strong focus on service processes
  • Bachelor’s degree in engineering, or a related field

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