Head of Business Quality, Global Operations Processes (m/f)
Driven by the passion to improve quality of life, WS Audiology continues to expand access to hearing care through innovative solutions, strong brands, and operational excellence. As part of our ongoing transformation, we are strengthening our global quality organization and looking for a leader to drive standardization, governance, and continuous improvement across critical operational quality processes.
What you will do
As Head of Business Quality, Global Operations Processes, you will own and govern key global quality processes across Operations, ensuring consistent execution, regulatory compliance, and continuous improvement across the organization.
The role serves as the Global Process Owner for Non-Conformance Management and selected Quality Operations processes, including Validation, Operational SOPs, NPI, and Design Transfer. You will act as the central point of contact for quality escalations, process governance, and cross-functional quality improvement initiatives.
Global Process Ownership & Governance
Serve as the Global Process Owner for Non-Conformance (NC) Management, ensuring standardized and compliant execution across regions and production sites.
Govern global quality operations processes, including Validation, Operational SOPs, NPI, and Design Transfer.
Define process standards, KPIs, and governance frameworks to drive consistency and effectiveness.
Drive harmonization of quality processes, systems, and best practices across global operations.
Quality Operations & Escalation Management
Lead critical quality escalations arising from non-conformances and operational quality events.
Ensure timely investigation, documentation, escalation, and closure of quality events in line with internal and regulatory requirements.
Facilitate effective root cause analysis and CAPA implementation to prevent recurrence.
Provide visibility and decision support for high-impact quality issues.
Continuous Improvement & Compliance
Monitor process performance through quality metrics and trend analysis, identifying opportunities for improvement and risk reduction.
Drive continuous improvement initiatives related to NC management, operational quality processes, and systemic quality risks.
Ensure compliance with applicable regulations and standards, including ISO 13485, EU MDR, and FDA requirements.
Support internal audits, external audits, and regulatory inspections.
Leadership & Stakeholder Management
Lead and develop a growing team responsible for global quality process governance.
Build strong partnerships across Operations, Engineering, Customer Service, Commercial, Regulatory Affairs, and Quality functions.
Influence stakeholders at all levels to drive alignment, accountability, and operational excellence.
Strategic Projects
Lead the implementation of a new global Non-Conformance Management system.
Drive process harmonization and change management initiatives.
Support strategic quality and business transformation projects across the organization.
What you bring
Experience
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline; Master's degree preferred.
10+ years of experience in Quality Engineering, Quality Operations, Manufacturing Quality, or related quality functions within the medical device industry or another highly regulated environment.
Strong experience with Non-Conformance Management, deviation investigations, root cause analysis, CAPA, and quality event management.
Proven experience governing global quality processes and driving cross-functional process improvements.
Experience supporting manufacturing operations and operational quality processes in a global environment.
Demonstrated experience working with quality management systems and regulatory requirements, including ISO 13485, EU MDR, and FDA regulations.
Experience supporting audits, inspections, and regulatory interactions.
Experience implementing, optimizing, or deploying quality management systems and digital quality tools is highly desirable.
Personal Competencies
Strategic mindset with strong leadership and decision-making capabilities.
Strong communication and stakeholder management skills, with the ability to influence without direct authority.
Proven ability to lead through complexity and manage high-priority quality escalations.
Analytical and data-driven approach to problem solving and process improvement.
Ability to operate effectively in a fast-paced, global environment with evolving priorities.
Strong commitment to quality excellence, compliance, and continuous improvement.
Collaborative leadership style with a passion for developing people and building high-performing teams.
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.
- Department
- Quality
- Role
- Business Quality
- Locations
- Komorniki, Poland
- Employment type
- Full-time
