EMEA Quality Lead – Medical Devices & Compliance

Cochlear; Venlo; On-site; EUR 65,000 - 90,000; Full time

Job summary

Cochlear is seeking a Regional Senior Quality Specialist to establish and maintain the EU Distribution Center’s QMS, ensuring compliance with quality, regulatory and business requirements. You’ll provide onsite quality support, manage core quality processes and drive improvements across the region.

This 12-month contract role involves audits, NCR management, CAPA, and collaboration with Quality, Supply Chain and Operations to sustain audit readiness and product lifecycle activities.

Qualifications

• At least 3 years of proven medical device quality experience at specialist level.
• Experience implementing quality processes, systems and reporting tools.
• Knowledge and practical experience of ISO 13485 and applicable European requirements, including EU MDR.
• Experience with operational quality in a sales and distribution environment.
• Experience with continuous improvement methodologies and process control techniques.
• Experience supporting non-conformance management, audits, investigations, root cause analysis and corrective actions.
• Strong project management, organisational and delivery skills.
• Ability to quickly develop detailed knowledge of a broad product portfolio.
• Excellent communication and stakeholder management skills across all levels of an organisation

Responsibilities

• Manage key operational quality processes, including non-conformance reports (NCRs), quarantine, quality holds, field actions, line clearance and escalation to manufacturers.
• Provide onsite quality support to the EU Distribution Center, including goods-in inspection oversight, facility walkarounds and monitoring of facility and stock controls.
• Conduct routine internal audits and help maintain continuous audit readiness, including support for external regulatory audits and regional manufacturing activities.
• Support regional investigations of customer complaints and facilitate root cause analysis, corrective actions and CAPA communications.
• Enact and support QMS processes covering document and records management, change control, training, internal audit, management review and quality objectives.
• Support product introduction, change and retirement activities, including EU importer and distributor compliance for third-party products.
• Partner with Supply Chain and operational teams through daily, weekly and monthly meetings, representing Quality and progressing actions that support compliant supply.
• Review new and changed QMS documents and guide business partners through process development, procedural change and implementation.
• Design and deliver quality training and help build a strong culture of quality awareness across the site.
• Lead continuous improvement projects across the region, identifying practical ways to streamline processes and strengthen operational controls.

Skills

Quality management

Regulatory compliance

Project management

Stakeholder management

Continuous improvement

Root cause analysis

Quality training

Job description

Cochlear is seeking a Regional Senior Quality Specialist to establish and maintain the EU Distribution Center’s QMS, ensuring compliance with quality, regulatory and business requirements. You’ll provide onsite quality support, manage core quality processes and drive improvements across the region.

This 12-month contract role involves audits, NCR management, CAPA, and collaboration with Quality, Supply Chain and Operations to sustain audit readiness and product lifecycle activities.