QMS Excellence Specialist - Medical Devices

WSA – Wonderful Sound for All; gmina Komorniki; On-site; PLN 120,000 - 180,000; Full time

Job summary

WSA – Wonderful Sound for All is seeking a Quality Management professional to lead the ongoing development and enhancement of our global QMS. You will ensure compliance with medical device standards, document control, training management, CAPA, internal audits, and change control across the organization.

In a dynamic, global environment, you will collaborate with R&D, Operations and regulatory teams to maintain audit readiness and drive continuous improvement in quality processes and

Qualifications

• 3+ years in a regulated industry (medical devices preferred).
• Strong English written and verbal communication.
• Experience with electronic QMS platforms.
• Hands-on with document control, training management, CAPA, internal audits, change control.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.

Responsibilities

• Support maintenance and continuous improvement of the Quality Management System (QMS).
• Ensure documentation quality, compliance, consistency, and audit readiness.
• Coordinate with stakeholders to clarify requirements and align on documentation updates.
• Manage the complete document lifecycle: creation, review, approval, distribution, revision, archival.
• Support internal audits, certification audits, and regulatory inspections.
• Provide quality guidance to cross-functional teams including R&D and Operations.
• Support training activities related to quality processes and regulatory requirements.
• Contribute to continuous improvement opportunities within the QMS.

Skills

Quality management

Documentation

CAPA

Internal audits

Regulatory knowledge

Tools

Electronic QMS platform

Job description

WSA – Wonderful Sound for All is seeking a Quality Management professional to lead the ongoing development and enhancement of our global QMS. You will ensure compliance with medical device standards, document control, training management, CAPA, internal audits, and change control across the organization.

In a dynamic, global environment, you will collaborate with R&D, Operations and regulatory teams to maintain audit readiness and drive continuous improvement in quality processes and