Junior Medical Device Quality & Complaint Specialist

Etac GmbH; Arnoldstein; Vor Ort; EUR 32.000 - 42.000; Vollzeit

Zusammenfassung

Klaxon Mobility, part of the Etac Group, is seeking a Junior Quality Complaint Officer to join the team in Arnoldstein, Austria. You will coordinate and investigate customer complaints related to medical devices, ensuring compliance and thorough documentation.

This role offers an early career path in Quality and regulatory affairs, with cross-functional collaboration across R&D, Production, and Regulatory Affairs, and exposure to Post Market Surveillance.

Qualifikationen

• Minimum 1–2 years in QA, tech support, regulatory affairs, or similar.
• Experience with technical investigations and root cause analyses.
• English proficiency at B2 level; Italian a plus.
• Experience in medical devices or regulated manufacturing is advantageous.

Aufgaben

• Act as the primary point of contact for customer complaints related to medical devices and associated products, ensuring each case is promptly assessed, documented, and managed through to closure.
• Coordinate complaint investigations with R&D, Production, and Quality & Regulatory Affairs teams.
• Ensure complaints are processed, investigated, and closed within established timelines.
• Maintain accurate complaint records in the quality management system with full traceability and compliance.
• Document investigation findings, conclusions, and root cause analyses in a clear and structured manner.
• Identify complaint trends and contribute to Post Market Surveillance activities.
• Support risk assessments, CAPA, vigilance reporting, and continuous improvement initiatives arising from complaint investigations.

Kenntnisse

Quality Assurance

Regulatory Compliance

Root Cause Analysis

Investigation

Documentation

English Proficiency

Ausbildung

Technical diploma or degree in a technical or scientific discipline

Jobbeschreibung

Klaxon Mobility, part of the Etac Group, is seeking a Junior Quality Complaint Officer to join the team in Arnoldstein, Austria. You will coordinate and investigate customer complaints related to medical devices, ensuring compliance and thorough documentation.

This role offers an early career path in Quality and regulatory affairs, with cross-functional collaboration across R&D, Production, and Regulatory Affairs, and exposure to Post Market Surveillance.