Poznań, Poznań, Greater Poland Voivodeship, Polska
LiNA Medical
14. 12. 2025
Informacje o stanowisku
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, final reporting.
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.
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. Trigger risk analysis updates when necessary.
Our requirements:
University in Quality Management, Engineering, or related
Minimum 2 years of experience in a similar position.>
Strong quality mindset and attention to detail.
Familiarity with ISO 13485 or ISO 9001 standards.
Experience with quality tools and methodologies (e.g., 5 Whys, Ishikawa Diagram, 8D Report).
Proficiency in MS Office (PowerPoint, Excel)
English proficiency at B2 level or higher.
Assertiveness and a positive, solution‑oriented approach.
Strong communication and problem‑solving skills.
Experience in the medical device industry is a plus
Knowledge of Medical Device Regulation (MDR) and FDA requirements is a plus.
We offer:
Full‑time job contract;
Opportunity to work in an international environment;
A number of benefits (private medical care, sports card, MyBenefit cafeteria, 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;