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.Work Location : Rome – Italy – Viale Ostiense 131 / LKey ResponsibilitiesService Support :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 correct 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.Equipment Management : Manage the equipment calibration and control the calibration expirations.Non-conformities Management : Open and manage the non-conformities issued during the service process, correction, and corrective action.Complaint Management : Manage the complaint activities. Ensure that activities are correctly carried out and registered.Problem Solving : Support the Lead Service Engineer in implementing corrective actions to minimize disruptions. Ensure activities are correctly carried out and registered.Training : Ensure that training and guidance to external parties are correctly registered.Compliance : Support Regulatory Affairs in ensuring compliance with all relevant regulations, including FDA, ISO, and other international standards.Internal Audit : Assist the Quality Assurance Manager in evaluating the service process’s compliance with all relevant regulations, including FDA, ISO, and other international standards.Qualification – Required Knowledge, Skills and AbilitiesKnowledge of 2017/745 (MDR) and 21 CFR 820.Knowledge of ISO 13485:2021.Skills :Strong technical troubleshooting and problem-solving skills.Excellent communication and collaboration abilities.Proficiency in English (writing and speaking).Personal Attributes :Ability to work independently and collaboratively across multifunctional teams.Resilient and capable of working effectively under stress and tight deadlines.Willingness to travel as needed.Minimum Required Education and ExperienceExperience : At least 2 years in a quality assurance role within the medical devices or healthcare industry, focusing on service processes.Education : Bachelor’s degree in engineering or a related field.Physical RequirementsExpected travel: 20%.ApplyEmail us attaching your CV, portfolio, and a motivational letter.J-18808-Ljbffr
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