Global Complaint Unit Specialist, Medical Devices

WS Audiology Group; Poznań; On-site; PLN 120,000 - 200,000; Full time

Job summary

WS Audiology Group is seeking a DCU Specialist to support global complaint handling in a regulated medical device environment. You will triage, document, and help investigate complaints, ensuring audit-ready records and timely escalation to CAPA and related processes.

You will collaborate with Quality, Regulatory, R&D, Manufacturing, and Customer Support to improve procedures and data analytics for ongoing product quality across our global portfolio.

Qualifications

• BSc in Engineering, Life Sciences, Quality, or related field.
• Experience in medical device complaint handling or related QA areas.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971 and medical device QMS requirements.
• Experience in regulated medical device environments.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication; cross-functional collaboration.
• Ability to manage multiple priorities with attention to documentation.

Responsibilities

• Perform intake, review, triage, evaluation, and documentation of product complaints.
• Ensure records are complete, accurate, and compliant with procedures and regulatory requirements.
• Support classification, risk assessment, and escalation to investigations and CAPA.
• Maintain complaint files for traceability and audit readiness.
• Support improvement of complaint handling procedures, workflows, and systems.
• Ensure activities meet established timelines and KPIs.
• Collaborate with R&D, Regulatory, Manufacturing, and other stakeholders on investigations.
• Review investigation documentation and ensure proper closure and corrective actions.
• Contribute data for trending, metrics, and PM/quality reviews.

Skills

Analytical thinking

Written and verbal communication

Cross-functional collaboration

Attention to detail

Education

BSc in Engineering, Life Sciences, Quality, or related field

Master's degree (preferred)

Tools

eQMS

TrackWise

Veeva

IQVIA

Job description

WS Audiology Group is seeking a DCU Specialist to support global complaint handling in a regulated medical device environment. You will triage, document, and help investigate complaints, ensuring audit-ready records and timely escalation to CAPA and related processes.

You will collaborate with Quality, Regulatory, R&D, Manufacturing, and Customer Support to improve procedures and data analytics for ongoing product quality across our global portfolio.