EMEA Quality Leader: Strategy, Compliance & Impact

WSA – Wonderful Sound for All; gmina Komorniki; On-site; PLN 180,000 - 280,000; Full time

Job summary

WS Audiology is seeking a Regional Head of Business Quality to lead regional quality strategy across multiple sites in EMEA, ensure regulatory compliance, and drive continuous improvement in quality performance. The role emphasizes strategic leadership, cross-functional collaboration, and strong governance of QMS and CAPA processes.

The position requires extensive experience in medical device quality, global regulatory requirements, and the ability to manage a diverse international team while

Qualifications

• 15+ years of experience in quality assurance and regulatory affairs in medical devices or pharma.
• Strong knowledge of QMS (ISO 13485, FDA 21 CFR Part 820, EU MDR) and regulatory requirements.
• Experience leading international teams across multiple sites.

Responsibilities

• Lead regional quality strategy, ensuring regulatory compliance and operational performance.
• Oversee quality systems, audits, inspections, CAPA, change control, and metrics.
• Provide quality leadership for manufacturing and distribution, including NPI and transfers.
• Manage customer-related quality processes and escalation pathways.

Skills

Quality leadership

Regulatory compliance

Cross-functional collaboration

Strategic planning

Stakeholder management

Job description

WS Audiology is seeking a Regional Head of Business Quality to lead regional quality strategy across multiple sites in EMEA, ensure regulatory compliance, and drive continuous improvement in quality performance. The role emphasizes strategic leadership, cross-functional collaboration, and strong governance of QMS and CAPA processes.

The position requires extensive experience in medical device quality, global regulatory requirements, and the ability to manage a diverse international team while