Our customer is dedicated to innovation, quality, and safety in medical technology.
Your Responsibilities
In this role, you will take ownership of the end-to-end customer complaint handling lifecycle-from initial receipt through root cause investigation to final closure. You will serve as a vital link in maintaining device safety and driving continuous product improvement.
Complaint Management: Receive, review, and log complaints in the complaint handling system, ensuring complete documentation, traceability, and timely resolution.
Technical Investigations: Coordinate and perform root cause analyses (using tools like 5-Why, Fishbone/Ishikawa) in close collaboration with R&D, Production, and Regulatory Affairs.
Risk & Trend Analysis: Identify quality trends, support Post-Market Surveillance (PMS) activities, and promptly escalate potential safety issues or reportable events to the Quality Assurance Manager.
CAPA & Continuous Improvement: Support and recommend CAPA and Non-Conformance (NCR) initiatives resulting from complaint findings, contributing to cross-functional risk management and quality enhancements.
Stakeholder Communication: Maintain factual, objective, and professional communication with distributors, service partners, and customers regarding complaint status and updates.
Your Profile
Education & Experience:
Education: Technical diploma or a Bachelor's degree in a technical or scientific discipline.
Experience: Experience in Quality Assurance, complaint handling, customer quality, technical support, or regulatory affairs-preferably within a regulated manufacturing environment (Medical Devices).
Technical Skills: Proven experience in conducting technical root cause investigations and working with complaint management or ERP systems.
Regulatory Knowledge: Solid understanding of ISO 13485 and medical device quality management system requirements.
Competencies & Mindset:
Language Skills: English proficiency (B1 level minimum, mandatory). Italian (B2 level) is a distinct advantage ("nice to have").
Working Style: Strong analytical and problem-solving skills, high attention to detail, and a structured, objective approach to documentation.
Personal Traits: Self-starter with strong communication skills, sound professional judgment, customer focus, and a collaborative team-player mindset.
What We Offer
A varied, high-impact role within a dynamic medical device environment.
The opportunity to actively shape product safety and improve patient quality of life.
A supportive, professional team culture with short communication lines.
We are looking forward to your application!
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