EU Regional Senior Quality Specialist - Quality Lead

C68 Cochlear Deutschland GmbH and Co. KG – Dutch branch; 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 EMEA Quality Management System within the EU Distribution Center. You will provide hands-on quality support, drive core processes, and lead improvements across the region.

This 12-month contract offers a path to permanent status within a collaborative Quality team. Ideal candidates have 3+ years in medical device quality, strong knowledge of ISO 13485 and EU MDR, and experience with audits, CAPA, and

Qualifications

• 3+ years of medical device quality experience at specialist level.
• Experience implementing or enacting quality processes and reporting tools.
• Knowledge of ISO 13485 and EU MDR quality system requirements.
• Experience with non-conformance management, audits, investigations, root‑cause analysis and corrective actions.

Responsibilities

• Manage key operational quality processes (NCRs, quarantine, quality holds, field actions, line clearance).
• Provide onsite quality support to the EU Distribution Center, including goods‑in inspection oversight and stock controls.
• Conduct internal audits and support regulatory audits and regional manufacturing activities.
• Support investigations of customer complaints and lead root‑cause analysis and CAPA communications.
• Enact QMS processes including document control, training and management review.

Skills

Quality management

Regulatory compliance

Risk-based decision making

Project management

Audits & CAPA

Tools

ISO 13485

EU MDR

Job description

Cochlear is seeking a Regional Senior Quality Specialist to establish and maintain the EMEA Quality Management System within the EU Distribution Center. You will provide hands-on quality support, drive core processes, and lead improvements across the region.

This 12-month contract offers a path to permanent status within a collaborative Quality team. Ideal candidates have 3+ years in medical device quality, strong knowledge of ISO 13485 and EU MDR, and experience with audits, CAPA, and