EMEA Head of Quality Excellence

WSA EMEA; gmina Komorniki; On-site; PLN 301,000 - 516,000; Full time

Job summary

WS Audiology seeks a Senior Director of Quality, Regulatory Affairs and Compliance to lead regional quality operations across 15+ countries. You will shape the global quality strategy, ensure QMS alignment with ISO 13485, FDA 21 CFR Part 820, EU MDR, and drive continuous improvement.

You will lead a 30+ person team, partner with executive leadership, manage audits and CAPA, and ensure manufacturing quality, product registrations, and customer quality processes.

Qualifications

• 15+ years in QA and/or Regulatory Affairs in medical devices or pharma.
• Strong QMS experience (ISO 13485, FDA 21 CFR Part 820, EU MDR).
• Experience supporting manufacturing operations and lifecycle quality.
• Proven leadership of international teams across sites.
• Experience with remediation, regulatory gap assessments, and CAPA.

Responsibilities

• Implement global quality strategy and region-specific quality plans.
• Foster a strong quality culture across regional operations.
• Partner with executive leadership to support strategic initiatives.
• Ensure compliant QMS across regional entities and audits.
• Oversee audits, inspections, and regulatory readiness.
• Lead end-to-end quality for production and distribution.
• Drive CAPA, nonconformance, and root cause investigations.
• Oversee customer-related quality processes and complaint handling.
• Maintain licenses and regulatory approvals for marketed products.
• Lead a 30+ person regional quality organization across 15+ countries.

Skills

Quality leadership

Regulatory affairs

QMS implementation

Cross-functional leadership

Stakeholder management

Data-driven decisions

Education

Bachelor's or higher in QA/Regulatory

Job description

WS Audiology seeks a Senior Director of Quality, Regulatory Affairs and Compliance to lead regional quality operations across 15+ countries. You will shape the global quality strategy, ensure QMS alignment with ISO 13485, FDA 21 CFR Part 820, EU MDR, and drive continuous improvement.

You will lead a 30+ person team, partner with executive leadership, manage audits and CAPA, and ensure manufacturing quality, product registrations, and customer quality processes.