Medical Device Complaint & Quality Analytics Specialist

WSA – Wonderful Sound for All; gmina Komorniki; On-site; PLN 60,000 - 120,000; Full time

Job summary

WSA – Wonderful Sound for All is seeking a meticulous Quality / Complaint Handling professional to support medical device post-market activities in Poland. You will review complaints, assist investigations, and help ensure regulatory compliance across ISO 13485 and 21 CFR 820 frameworks.

Responsibilities include data trending, CAPA integration, and cross-functional collaboration with R&D, Manufacturing, and Regulatory teams to improve product quality and patient safety.

Qualifications

• BSc in Engineering, Life Sciences, Quality, or a related field.
• Experience in medical device complaint handling, quality assurance, post-market quality, or related areas.
• Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, and medical device quality system requirements.
• Experience working within a regulated medical device environment.
• Strong analytical and problem‑solving skills.
• Strong written and verbal communication skills.
• Ability to collaborate effectively across functions and cultures.
• Experience using electronic quality management systems (eQMS).

Responsibilities

• Handle intake, review, triage, evaluation and documentation of product complaints.
• Support complaint classification, risk assessment and escalation to CAPA and other quality processes.
• Maintain complaint files for traceability and audit readiness.
• Assist in continuous improvement of complaint handling procedures and systems.
• Ensure activities meet established timelines and KPIs.
• Collaborate with Regulatory Affairs, R&D, Manufacturing, Supply Chain and Customer Support.
• Support investigations and follow-up actions related to complaints.
• Contribute to data review, trending and post-market surveillance activities.

Skills

Analytical thinking

Communication skills

Attention to detail

Documentation

Collaboration

Adaptability

Education

BSc in Engineering/Life Sciences/Quality

Master's degree (preferred)

Tools

eQMS

TrackWise

Veeva

IQVIA

Job description

WSA – Wonderful Sound for All is seeking a meticulous Quality / Complaint Handling professional to support medical device post-market activities in Poland. You will review complaints, assist investigations, and help ensure regulatory compliance across ISO 13485 and 21 CFR 820 frameworks.

Responsibilities include data trending, CAPA integration, and cross-functional collaboration with R&D, Manufacturing, and Regulatory teams to improve product quality and patient safety.