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.

Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.