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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