QMS Specialist (Corporate QMS)

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

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.