Quality Assurance Engineer - Medical Devices
Location: Mirandola, Italy
Contract: 12‐months (freelance)
Overview
We 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 R&D teams.
Responsibilities
* Conduct structured root cause analysis using established engineering and quality tools (fishbone diagrams, failure analysis, decision trees, FMEA, etc.).
* Evaluate product performance data, identify trends, and develop engineering‐driven recommendations to enhance product reliability and manufacturing processes.
* Ensure quality documentation-including technical reports, investigations, and change records-is complete, accurate, and compliant with FDA, ISO 13485, and EU MDR standards.
* Support regulatory and compliance activities, including audit preparation, data gathering, and representation as a Quality SME during internal and external audits.
* Contribute to CAPA and NCR investigations by providing engineering insight and supporting the implementation of corrective and preventive actions.
* Support product quality activities across the full lifecycle, including risk management, design review support, and process verification activities.
* Collaborate with Engineering, Quality, Operations, and R&D teams to investigate product‐related issues and implement robust technical solutions.
Qualifications
* Bachelor's degree in Engineering preferred
* 3-5 years of experience within the medical device industry
* Strong engineering mindset with the ability to analyse technical data and troubleshoot product or process issues.
* Excellent documentation, reporting, and analytical skills; proficiency in Microsoft Office (Excel, Word, PowerPoint).
* Ability to work independently, manage multiple priorities, and maintain strong attention to detail.
* Effective communicator with experience presenting technical findings to senior leadership and cross‐functional stakeholders.