QMS Specialist (Corporate QMS) (M/K)

QMS Specialist (Corporate QMS) (M/K)

Miejsce pracy: Komorniki (gm. Komorniki)

Your responsibilities

• 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

Our requirements

• 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.

Benefits

• sharing the costs of sports activities
• private medical care
• sharing the costs of foreign language classes
• life insurance
• remote work opportunities
• flexible working time
• fruits
• corporate products and services at discounted prices
• integration events
• no dress code
• employee referral program
• charity initiatives
• family picnics
• Benefits platform

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.

WS Audiology

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.