Global QMS & CAPA Specialist for Medical Devices

WS Audiology Group; Komorniki; Hybrid; PLN 150,000 - 220,000; Full time

Job summary

WS Audiology Group is seeking a Quality Management System Specialist to maintain and improve our global QMS, ensuring compliance with ISO 13485 and FDA regulations. You will work with R&D, Operations, and other teams to drive quality across the organization.

The role emphasizes documentation control, CAPA, internal audits, and training activities, with a focus on continuous improvement in a fast-paced, global environment.

Qualifications

• Minimum 3 years of experience in a regulated industry, preferably medical devices.
• Strong English communication skills, both written and verbal.
• Experience with electronic QMS platforms and documents.
• Hands-on experience with QMS processes such as document control, training management, CAPA, internal audits, change control.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.

Responsibilities

• Maintain, develop and continuously improve the global Quality Management System to ensure compliance with medical device regulations and standards.
• Support operational excellence by ensuring quality processes are implemented, documented, and monitored.
• Coordinate with stakeholders to clarify requirements and updates to documentation.
• Manage the entire document lifecycle: creation, review, approval, distribution, revision, archival.
• Ensure documentation quality, consistency, and audit readiness.
• Support documentation initiatives and process improvement projects.
• Provide quality guidance to cross-functional teams including R&D and Operations.
• Support internal and certification audits and regulatory inspections.
• Assist training activities related to quality processes and regulatory requirements.
• Contribute to global CAPAs as CAPA Owner or related roles.

Skills

Quality Management

Document Control

CAPA Management

Regulatory Compliance

QMS Software

English Communication

Job description

WS Audiology Group is seeking a Quality Management System Specialist to maintain and improve our global QMS, ensuring compliance with ISO 13485 and FDA regulations. You will work with R&D, Operations, and other teams to drive quality across the organization.

The role emphasizes documentation control, CAPA, internal audits, and training activities, with a focus on continuous improvement in a fast-paced, global environment.