Regional Senior Quality Specialist – EU Medical Devices

Cochlear Limited; Venlo; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cochlear Limited in Venlo, NL, is seeking a Regional Senior Quality Specialist to help establish and maintain the EU/EMEA QMS for the EU Distribution Center. You will provide hands-on support to site operations, drive audits, CAPA, change controls and supplier quality, and partner with Quality, Supply Chain and Operations to ensure regulatory compliance.

The role is initially for 12 months with potential to become permanent, requiring strong experience in medical device quality, ISO 13485 and EU

Qualifications

• At least 3 years of medical device quality experience.
• Experience implementing quality processes, systems and reporting tools.
• Knowledge of ISO 13485 and EU MDR requirements.
• Experience with audits, non-conformance, investigations and CAPA.
• Strong project management and stakeholder management.
• Excellent communication across all levels of the organization.
• English fluency required; Dutch and/or German desirable.

Responsibilities

• Manage key operational quality processes including NCRs, quarantine, holds, field actions, line clearance and escalation to manufacturers.
• Provide onsite quality support to the EU Distribution Center, including goods-in inspection oversight and stock controls.
• Conduct routine internal audits and support regulatory audits and regional manufacturing activities.
• Support regional investigations of customer complaints and facilitate root cause analysis, CAPA communications.
• Enact and support QMS processes covering document/control, change control, training, internal audit, and management review.
• Support product introduction, change and retirement activities for EU importer/distributor compliance.
• Partner with Supply Chain and operations through regular meetings to progress quality actions.
• Review new and changed QMS documents and guide partners through process changes.
• Design and deliver quality training and promote quality awareness across the site.
• Lead continuous improvement projects across the region to streamline processes and strengthen controls.

Skills

Quality management

Regulatory compliance

Project management

Communication skills

Stakeholder management

Job description

Cochlear Limited in Venlo, NL, is seeking a Regional Senior Quality Specialist to help establish and maintain the EU/EMEA QMS for the EU Distribution Center. You will provide hands-on support to site operations, drive audits, CAPA, change controls and supplier quality, and partner with Quality, Supply Chain and Operations to ensure regulatory compliance.

The role is initially for 12 months with potential to become permanent, requiring strong experience in medical device quality, ISO 13485 and EU