Quality Assurance Specialist.

Overview

In this role you will support commercial Quality Assurance and Regulatory Compliance (QARC) across the EMEA region, ensuring adherence to quality systems and medical device standards. You will collaborate with affiliates, distributors, and cross-functional teams to sustain high-quality warehousing, inventory, and distribution processes. You will lead quality improvements, audits, and CAPA activities to mitigate risk and ensure audit readiness. This is an opportunity to shape quality practices within a global healthcare leader and make a tangible impact on patient outcomes.

Responsibilities

• Implement and maintain QA requirements for warehousing, inventory, and distribution across EMEA
• Support distribution and warehousing quality processes with partners
• Collaborate with Sales, Marketing, Customer Service, and Supply Chain to align quality requirements
• Support distributor onboarding and annual quality processes
• Monitor field inventory quality, identify and mitigate quality risks
• Qualify, evaluate, and monitor third-party suppliers and distributors
• Manage CAPA investigations and implement corrective actions
• Deliver quality training related to inventory, warehousing, and distribution
• Participate in audits and support audit readiness
• Develop and maintain quality procedures and documentation
• Escalate warehousing, inventory, and distribution quality risks to EMEA QA leadership

Key requirements

• 2-4 years of experience in QA, supply chain quality, warehousing, or related regulated field
• Knowledge of ISO 13485 and Medical Device Regulations
• Experience in a QMS environment
• Strong analytical, problem-solving, and investigation skills
• Experience managing CAPAs and supporting audits
• Excellent communication and stakeholder management
• Ability to work cross-functionally in an international setting

• Excellent communication
• Stakeholder management
• Cross-functional collaboration
• ISO 13485
• Medical Device Regulations
• Quality Management System (QMS)

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