Complaints Engineer I – Medical Device Quality Assurance

About the role

We are seeking a Complaints Engineer I to join our manufacturing quality assurance team. The role focuses on investigating customer complaints for medical devices, ensuring compliance with global regulatory standards and supporting continuous product improvement.

Key responsibilities

• Generate and analyse reports from the electronic complaint management system to identify trends and track issues.
• Conduct thorough investigations of assigned complaints within defined timelines, including sample evaluation, documentation review, personnel interviews and trend analysis.
• Collaborate with cross‑functional teams to determine root causes and document findings in the electronic quality system.
• Prepare detailed investigation reports, notify supervisors of adverse events, and support risk assessments.
• Present complaint summaries, trends and investigation outcomes to multifunctional teams.
• Participate in projects aimed at product quality, process improvement and regulatory compliance.

Required profile

• 1‑2 years of experience in a similar role within the medical‑device industry.
• Familiarity with regulatory standards such as 21 CFR 820, ISO 13485, EU MDR and other regional requirements.
• Ability to work under close supervision and follow established procedures.

Required skills

• Advanced proficiency in Microsoft Excel for data analysis and reporting.
• Strong command of the Microsoft Office suite.
• Experience using an electronic complaint management system.