Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a world full of sound. We aim to transform the way people understand and treat hearing loss and innovate to connect people with future technologies. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping more people to experience a lifetime of hearing.
The Opportunity
Cochlear is seeking a Regional Principal Quality Specialist to lead and drive quality compliance and continuous improvement across the EMEA region. This role ensures adherence to global and regional regulatory requirements, ISO standards, and Cochlear’s Quality Management System (QMS), while partnering with cross-functional teams to deliver exceptional product quality and customer experience.
This is a permanent, full-time role based at our European Distribution Centre in Venlo, Netherlands with both site and regional responsibilities across EMEA.
Your responsibilities will include:
Act as the regional quality lead, ensuring compliance with ISO 13485, EU MDR, and other applicable regulations
Develop, implement, and monitor quality strategies, policies, and procedures across EMEA operations
Provide expert guidance on regulatory requirements and quality standards to internal stakeholders
Lead audits (internal and external) and manage corrective and preventive actions (CAPA) to maintain audit readiness
Partner with Operations, Supply Chain, and Commercial teams to ensure quality objectives are met
Drive continuous improvement using a variety of methodologies and process control techniques
Prepare and present quality performance reports, metrics, and trends to senior leadership
Support training and development programs to embed a strong quality culture across the region
About You:
Minimum:
Extensive experience in quality management within a regulated industry (medical devices or healthcare preferred)
Strong knowledge of ISO 13485, EU MDR, and global regulatory frameworks
Proven track record in leading audits and managing NCR/CAPA processes
Experience with operational quality in a sales and distribution environment
Excellent communication and stakeholder management skills across diverse cultures
Ability to analyse data and present actionable insights
Fluent in Dutch and English
Other:
This role is required to be onsite at the EU Distribution Center full time. Occasional travel within / outside of Europe may be required.
Ideal:
Experience with Oracle/SAP or similar ERP platforms
Experience with QMS/Electronic Document Management System platforms
Experience with continuous improvements methodologies and process control techniques
Familiarity with international distribution and supply chain quality requirements
Strong influencing skills and ability to lead change initiatives and change management
German language skills are a plus
Why Join Us?
This role offers the opportunity to shape quality strategy across a dynamic region, work with global teams, and contribute to Cochlear’s mission of helping people hear and be heard. You’ll gain exposure to complex regulatory environments and play a key role in driving operational excellence.
If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.
#CochlearCareers
How we recognise your contribution
At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.
For more information about Life at Cochlear, visit www.cochlearcareers.com