Customer Quality Engineer

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.