Cochlear is the global leader in implantable hearing solutions, helping people of all ages hear and connect with life. Our mission is to transform the way people experience sound by delivering innovative technology and world-class service.
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Join us in European Distribution Centre Team in Venlo, Netherlands and make a real difference in the lives of millions.
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.
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
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
* A Purpose‐Driven Career - Make a real impact by restoring hearing and changing lives
* A Collaborative & Innovative Environment
* Professional Development Opportunities
* Competitive Compensation & Benefits (including travel allowances & performance incentives)
Important:
* Applications and CVs must be in English
Ready to Make an Impact? Apply Today! Join us in changing lives through sound!
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. xjliken You'll gain exposure to complex regulatory environments and play a key role in driving operational excellence.