PstronguQuality Assurance Engineer - Medical Devices /u /strong /ppbrVuole candidarsi? Si assicuri che il suo CV sia aggiornato, poi legga attentamente le specifiche del lavoro prima di procedere.br/ppstrongLocation: /strongMirandola, Italy /ppstrongContract: /strong12‑months (freelance) /ppbr/ppstrongOverview /strong /ppWe are seeking a Quality Assurance Engineer to support key quality and engineering activities within a regulated medical device environment. This role will contribute to product quality, process improvement, and compliance efforts while collaborating closely with cross‑functional engineering, operations, and RD teams. /ppbr/ppstrongResponsibilities /strong /pulliConduct structured root cause analysis using established engineering and quality tools (fishbone diagrams, failure analysis, decision trees, FMEA, etc.). /liliEvaluate product performance data, identify trends, and develop engineering‑driven recommendations to enhance product reliability and manufacturing processes. /liliEnsure quality documentation-including technical reports, investigations, and change records-is complete, accurate, and compliant with FDA, ISO 13485, and EU MDR standards. /liliSupport regulatory and compliance activities, including audit preparation, data gathering, and representation as a Quality SME during internal and external audits. /liliContribute to CAPA and NCR investigations by providing engineering insight and supporting the implementation of corrective and preventive actions. /liliSupport product quality activities across the full lifecycle, including risk management, design review support, and process verification activities. /liliCollaborate with Engineering, Quality, Operations, and RD teams to investigate product‑related issues and implement robust technical solutions. /li /ulpbr/ppstrongQualifications /strong /pulliBachelor's degree in Engineering preferred /lili3-5 years of experience within the medical device industry /liliStrong engineering mindset with the ability to analyse technical data and troubleshoot product or process issues. /liliExcellent documentation, reporting, and analytical skills; proficiency in Microsoft Office (Excel, Word, PowerPoint). /liliAbility to work independently, manage multiple priorities, and maintain strong attention to detail. xdwybme /liliEffective communicator with experience presenting technical findings to senior leadership and cross‑functional stakeholders. /li /ul