Designated Complaint Unit (DCU) Specialist

WS Audiology Group; Poznań; Sur place; PLN 120 000 - 200 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Analytical thinking

Written and verbal communication

Cross-functional collaboration

Attention to detail

Formation

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

Master's degree (preferred)

Outils

eQMS

TrackWise

Veeva

IQVIA

Description du poste

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.

The DCU Specialist works closely with Business Quality, Regulatory Affairs, R&D, Manufacturing, Customer Support, and Post-Market Surveillance to ensure accurate complaint records, timely investigation support, and effective communication throughout the complaint handling process.

The position plays a key role in maintaining regulatory compliance, product quality, and continuous improvement across the company's global portfolio.

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

Experience

Required

• 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

Who we are

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. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.