Customer Quality Engineer

4 settimane fa

Mirandola, Italia LivaNova A tempo pieno

Join us today and make a difference in people's lives

We are seeking a Customer Quality Engineer to join our dynamic team.

This critical role involves managing customer complaints with a focus on electro-mechanical medical devices, including software-related issues. Collaboration with cross-functional teams across the globe will be part of your daily tasks to ensure tailored, fact-based, and timely responses. Your efforts will play a vital role in delivering product excellence and ensuring customer satisfaction.

Duties and Responsibilities

  • Manage and investigate customer complaints mainly, but not only, related to electro-mechanical medical devices, ensuring timely and accurate resolution.
  • Collaborate with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to clarify and address product-related issues.
  • Focus on software/hardware-related complaints, analyzing reported issues to determine root causes and corrective actions.
  • Design and implement specific test protocols to replicate and evaluate reported issues under controlled conditions.
  • Document findings and provide comprehensive reports to support continuous product improvement.
  • Ensure compliance with applicable regulatory standards and internal quality processes.
  • Document and report to management the results of the investigation.
  • Timely execute vigilance assessment and support the submission of Vigilance reports to Competent Authorities.
  • Support preparation of responses to inquiries from competent authorities.
  • Conduct assessment of risk in accordance with the international standards and internal procedures for the events he/she is responsible for.

The Individual

  • Bachelor’s degree in biomedical engineering, Software Engineering, Electrical Engineering, or a related field.
  • Strong organizational abilities to manage multiple tasks and priorities.
  • Excellent technical writing skills to produce clear, concise documentation.
  • Fluent in spoken and written English; proficiency in other languages, particularly German, is highly desirable.
  • Exceptional attention to detail and problem-solving capabilities.
  • Experience with electro-mechanical medical devices, including software components.
  • Familiarity with regulatory standards for medical devices (e.g., FdA 21 CFR, ISO 13485, IEC 60601).
  • Depth knowledge of Microsoft Office suite and Minitab, Python, SQL or other programming software is desirable.
  • Excellent communication skills and a collaborative mindset.
  • Mindset: Passionate about quality, driven by innovation, and customer oriented.
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