W skrócie
- Zadania: Zarządzaj skargami i wspieraj procesy jakości w branży urządzeń medycznych.
- Firma: WSA, lider w branży aparatów słuchowych, z globalnym zespołem 12,000 pracowników.
- Benefity: Możliwość pracy w międzynarodowym środowisku, rozwój kariery i wsparcie dla różnorodności.
- Pozostałe informacje: Doskonałe możliwości rozwoju kariery w dynamicznym i wspierającym zespole.
- Dlaczego ta praca: Przyczyń się do poprawy jakości życia ludzi na całym świecie.
- Kwalifikacje: Wykształcenie w dziedzinie inżynierii lub nauk przyrodniczych oraz doświadczenie w obsłudze skarg.
Przewidywane wynagrodzenie mieści się w przedziale 67500 - 82500 zł za rok.
Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively. We are looking for an ambitious colleague to join the Designated Complaint Unit (DCU) as a DCU Specialist. This role is responsible for supporting global complaint handling activities and ensuring complaints are assessed, documented, and processed in compliance with applicable medical device regulations and internal procedures.
What you will do
- Complaint Handling
- Perform intake, review, triage, evaluation, and documentation of product complaints.
- Ensure complaint records are complete, accurate, and compliant with applicable procedures and regulatory requirements.
- Support complaint classification, risk assessment, and escalation to Investigation, CAPA, and other relevant quality processes as needed.
- Maintain complaint files to ensure traceability and audit readiness.
- Support continuous improvement of complaint handling procedures, workflows, training, and systems.
- Ensure complaint handling activities are completed within established timelines and KPIs.
- Investigation Support
- Collaborate with Business Quality, R&D, Supply Chain, Manufacturing, and other stakeholders to support timely and thorough complaint investigations.
- Review investigation documentation for completeness and clarity.
- Ensure investigation outcomes are appropriately documented within the complaint record.
- Support follow-up activities related to complaint investigations and corrective actions.
- Data Review, Trending & Analysis
- Support the review and analysis of complaint data to identify trends and product performance signals.
- Assist in preparing complaint metrics and reports for Management Reviews and quality monitoring activities.
- Contribute data and insights to Post-Market Surveillance activities as required.
- Escalate emerging issues and trends through appropriate quality channels.
- Compliance, Audit Readiness & Documentation
- Maintain complaint records and supporting documentation in an audit-ready state.
- Participate in internal audits, external audits, and inspections as a complaint handling subject matter expert.
- Ensure compliance with applicable procedures, quality system requirements, and regulatory expectations.
- Support remediation and continuous improvement activities when gaps are identified.
- Cross-Functional Collaboration
- Work closely with Regulatory Affairs, Business Quality, R&D, Manufacturing, Supply Chain, and Customer Support.
- Support integration of complaint information into CAPA, risk management, and product improvement activities.
- Contribute to cross-functional initiatives aimed at improving product quality and customer satisfaction.
What you bring
- 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).
Preferred
- Master's degree in a relevant discipline.
- Experience with SaMD, electronic medical devices, or other Class IIa devices.
- Experience with QMS platforms such as TrackWise, Veeva, IQVIA, or similar systems.
- Experience supporting audits and regulatory inspections.
Personal competencies
- Attention to detail and documentation accuracy.
- Analytical and risk-based thinking.
- Strong organizational and prioritization skills.
- Effective communication and collaboration.
- Customer-focused mindset.
- Continuous improvement orientation.
- Ability to work independently and manage multiple priorities.
- Commitment to quality and compliance.
At WSA, we provide innovative hearing aids and hearing health services. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes. Sounds wonderful? We can't wait to hear from you. WSA is an equal-opportunity employer and committed to creating an inclusive employee experience for all.
Designated Complaint Unit (DCU) Specialist in Poznań – pracodawca: WS Audiology Group
WSA to dynamic i innowacyjna firma, która stawia na poprawę jakości życia ludzi poprzez swoje zaawansowane rozwiązania w zakresie aparatów słuchowych. Pracując jako Global Process Governance Analyst, będziesz częścią międzynarodowego zespołu, który ceni różnorodność i współpracę, oferując jednocześnie możliwości rozwoju zawodowego oraz wsparcie w realizacji ambitnych celów. Nasza kultura pracy opiera się na otwartości, wzajemnym szacunku i dążeniu do doskonałości, co czyni nas doskonałym pracodawcą dla osób poszukujących satysfakcjonującej i znaczącej kariery.
