Complaints and Vigilance Specialist – Praca Poznań Sady, Tarnowo Podgórne

Your responsibilities

• Register and manage customer complaints in a timely and accurate manner.
• Oversee the entire complaint-handling process—from registration, classification, root cause investigation, corrective action definition, IMDRF code assignment, final reporting, and financial corrections in the ERP system.
• Report incidents to relevant regulatory authorities worldwide.
• Continuously monitor and analyze market requirements related to trend reporting and regulatory expectations.
• Update internal procedures and reporting processes in response to regulatory changes.
• Monitor key complaint management indicators and prepare statistical reports.
• Supervise trend reporting processes to identify recurring issues and potential risks.
• Act as the primary contact for distributors and regulatory authorities regarding complaints and medical incidents.
• Collaborate closely with engineering, production, and quality control teams to investigate complaint root causes.
• Work with Product Managers and participate in regular status review meetings.
• Lead the complaint management team—facilitate root cause analysis meetings and define corrective actions.
• Participate in the Corrective and Preventive Actions (CAPA) process, including initiating CAPAs based on complaint trends.
• Align complaint handling with risk management processes, ensuring risk mitigation measures are properly implemented. Trigger risk analysis updates when necessary.

Our requirements

• University degree in Quality Management, Engineering, or a related
• Strong quality mindset and attention to detail.
• Familiarity with ISO 13485 standards.
• Minimum 2 years of experience in the medical device industry.
• Knowledge of Medical Device Regulation (MDR) and FDA requirements is a plus.
• Experience with quality tools and methodologies (e.g., 5 Whys, Ishikawa Diagram, 8D Report).
• Proficiency in MS Office (PowerPoint, Excel); Power BI is a plus.
• English proficiency at B2 level or higher.
• Assertiveness and a positive, solution-oriented approach.
• Strong communication and problem-solving skills.

What we offer

• Full-time job contract.
• Opportunity to work in an international environment.
• A number of benefits (private medical care, sports card, flexible working time, Home Office, co-financing for English language classes, fruit and snacks),
• Great atmosphere in the office and interesting challenges,
• Opportunity to grow with the organization and build a successful career path.
• Internal and external training.