QMS Specialist (Corporate QMS) (M/K)

WSA – Wonderful Sound for All; gmina Komorniki; Vor Ort; PLN 120.000 - 180.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality management

Documentation

CAPA

Internal audits

Regulatory knowledge

Tools

Electronic QMS platform

Jobbeschreibung

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.

As a member of the Corporate Quality Management System (QMS) team, you will be responsible for maintaining, developing and continuously improving the global Quality Management System to ensure compliance with applicable medical device regulations and standards. This role supports operational excellence by ensuring that quality processes are effectively implemented, documented, and monitored across the organization.

What you will do

• Support the maintenance and continuous improvement of the Quality Management System (QMS), ensuring effective implementation, documentation, and monitoring of quality processes across the organization
• Support the effective execution of quality processes to drive operational excellence
• Coordinate with stakeholders to clarify requirements and align on documentation updates
• Manage the complete document lifecycle, including creation, review, approval, distribution, revision, and archival
• Ensure documentation quality, compliance, consistency, and audit readiness
• Support documentation initiatives and process improvement projects
• Provide quality guidance and support to cross-functional teams, including R&D, Operations, and other stakeholders
• Support internal audits, certification audits, and regulatory inspections
• Support training activities related to quality processes, regulatory requirements, and compliance standards
• Support global CAPAs as a CAPA Owner, CAPA Action Owner, or other assigned role, with responsibility for executing service quality and documentation-related tasks
• Contribute to the identification and implementation of continuous improvement opportunities within the QMS.

What you bring

• Minimum 3 years of experience in a regulated industry, preferably within the medical device industry
• Strong English communication skills, both written and verbal
• Experience working with electronic QMS platforms and documents
• Hands-on experience with QMS processes such as document control, training management, CAPA, internal audits, change control
• Working knowledge of applicable quality standard and regulations, such as ISO 13485 and FDA 21 CFR Part 820.
• Personal Competences
  • Strong documentation, organizational, and time-management skills
  • High attention to detail with a strong focus on quality, compliance, and accuracy
  • Strong communication and collaboration skills, with the ability to work effectively across functions
  • Ability to work independently, prioritize multiple tasks, and meet deadlines
  • Proactive problem-solving mindset with a continuous improvement focus
  • Comfortable working in a dynamic, global environment.

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.