Direct message the job poster from Cosmo Intelligent Medical Devices
Cosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial intelligence.
Cosmo IMD has developed in recent years unrivaled expertise in multiple aspects related to the AI MedTech business, such as medical device Hardware and Software design, healthcare Artificial Intelligence development, medical data harvesting, clinical development, scientific production, and regulatory expertise in the US and worldwide.
Cosmo IMD team is manufacturing GI Genius, the world's first real-time artificial intelligence medical device that is globally distributed by Medtronic.
About the role Quality Service Operations
Service 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 the implementation of the corrective actions to minimize disruptions.
Ensure that activities are correctly carried out and registered.Training: ensure that the training and guidance to external parties are correctly registered.Compliance: Support the Regulatory Affairs in compliance with all relevant regulations, including FDA, ISO, and other international standards.Internal Audit: Support the Quality Assurance Manager in the service process's evaluation in compliance with all relevant regulations, including FDA, ISO, and other international standards.Qualification – Required Knowledge, Skills, and Abilities: Experience: 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.Education: Bachelor's degree in engineering, or a related field.Knowledge of 2017/745(MDR) and 21 CFR 820.Knowledge of 13485: 2016Skills: Strong technical troubleshooting and problem-solving skills.Excellent communication and collaboration abilities.Good English Level (writing and speaking).Personal Attributes: 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.Equal Opportunity Statement: The research complies with Legislative Decree 198/2006
Seniority levelAssociateEmployment typeFull-timeJob functionQuality AssuranceIndustries: Medical Equipment Manufacturing
#J-18808-Ljbffr