Complaints and Vigilance Specialist

About the role

LiNA Medical Polska, a manufacturer of minimally invasive gynecological medical devices, is looking for a Complaints and Vigilance Specialist in Poznań. The position is full-time and involves managing customer complaints, reporting incidents to regulators and leading the complaint management team.

Key responsibilities

• Register and manage customer complaints accurately and on time.
• Oversee the full complaint-handling process: registration, classification, root cause investigation, corrective actions, IMDRF code assignment, reporting and financial corrections in the ERP system.
• Report incidents to regulatory authorities worldwide and monitor market requirements for trend reporting and regulatory expectations.
• Update internal procedures and reporting processes in line with regulatory changes, and align complaint handling with risk management.
• Monitor complaint indicators, prepare statistical reports and supervise trend reporting to spot recurring issues and risks.
• Act as main contact for distributors and regulators, and collaborate with engineering, production and quality teams on root cause investigations.
• Work with Product Managers in status reviews, lead the complaint team, run root cause analysis meetings and initiate CAPAs based on complaint trends.

Required profile

• University degree in Quality Management, Engineering or a related field.
• At least 2 years of experience in the medical device industry.
• Familiarity with ISO 13485; knowledge of MDR and FDA requirements is a plus.
• B2-level English or higher; assertiveness, strong communication and problem-solving skills.

Required skills

• Quality tools such as 5 Whys, Ishikawa diagram and 8D report.
• MS Office (PowerPoint, Excel); Power BI is a plus.

What we offer

• Full-time job contract and an international working environment.
• Benefits including private medical care, sports card, flexible working hours, home office, co-financed English courses and fruit and snacks.
• Office atmosphere, growth opportunities and internal and external training.