EMEA Head of Quality Excellence

WS Audiology Group; Polska; 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

Driven by the passion to improve quality of life, WS Audiology positions itself as an essential market leader in the hearing aids market. Our ambition is to meet the needs of an underserved hearing care market and transform our organization to reach a broader audience with greater efficiency and inclusivity.

The Regional Head of Business Quality is a leadership position responsible for overseeing all aspects of quality assurance and providing dedicated support for business affiliates and manufacturing facilities in EMEA.

The role ensures the Quality Management System is consistently maintained across all business affiliates while carrying out daily quality processes and controls. It includes supporting sales and distribution activities, performing incoming inspections and final product release, overseeing change controls that may impact the local QMS or regulatory compliance, and conducting root‑cause analysis for manufacturing nonconformities along with managing local CAPAs. The Regional Head is responsible to create region-specific quality plans, strategies and action steps to achieve operational and regulatory compliance.

What you will do

Quality Strategy & Leadership

• Implement the global quality strategy and develop region-specific quality plans to ensure regulatory compliance and operational performance.

• Foster a strong quality culture across regional operations and leadership teams.

• Partner with executive leadership and cross-functional stakeholders to support strategic initiatives.

Quality Systems & Compliance

• Ensure implementation and maintenance of compliant Quality Management Systems across all regional entities.

• Oversee internal audit programs, regulatory inspections, and external audits (health authorities, customers, notified bodies).

• Ensure effective change control, CAPA, nonconformance management, training, and documentation processes.

• Monitor and review regional quality performance metrics and KPIs, supporting management review activities.

Operational Quality Oversight

• Provide quality leadership for manufacturing operations, including NPI, manufacturing transfers, and strategic projects.

• Ensure end-to-end quality assurance for production and distribution activities.

• Support root cause investigations and CAPA implementation for operational quality issues.

Customer & Service Quality

• Oversee customer-related quality processes, including complaint management and issue escalation.

• Ensure timely reporting, monitoring, and trending of product and service quality issues.

Regulatory Compliance

• Ensure compliance with local regulatory requirements, including facility and product registrations.

• Oversee regulatory inspection readiness and labelling/localization requirements.

• Maintain required licenses and regulatory approvals for marketed products.

Team Leadership

• Lead and develop a high-performing regional quality organization.

• Team Size of 30+ in 15+ countries/entities/affiliates.

• Promote talent development, leadership capability, and succession planning across the team.

What you bring

Experience

• 15+ years of experience in Quality Assurance and/or Regulatory Affairs within the medical device or pharmaceutical industry.

• Strong experience with Quality Management Systems (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR) and regulatory compliance.

• Experience supporting manufacturing operations, product lifecycle quality, and customer quality processes.

• Proven leadership experience managing international teams across multiple sites and cultures.

• Experience with QMS implementation, remediation activities, and regulatory gap assessments.

• Demonstrated ability to manage complex operations and drive continuous improvement initiatives.

Personal competencies

• Strategic mindset with strong leadership and decision-making capabilities.

• Strong communication and stakeholder management skills, with the ability to influence across functions and leadership levels.

• Analytical thinker with the ability to translate quality data into actionable insights.

• Ability to operate effectively in a fast-paced, global environment with evolving priorities.

• Committed to quality excellence, compliance, and continuous improvement.

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.