Quality Assurance Specialist.

This role will support the commercial Quality Assurance and Regulatory Compliance (QARC) activities across the EMEA region, based in Solihul, ensuring compliance with quality management systems, ISO standards, and medical device regulations. The successful candidate will work closely with affiliates, third-party logistics providers, distributors, and cross-functional teams to maintain high-quality warehousing, inventory, and distribution processes.

• Implement and maintain Quality Assurance requirements for warehousing, inventory, and distribution activities across EMEA.
• Support the implementation of distribution and warehousing quality processes with affiliates, distributors, and logistics partners.
• Partner with Sales, Marketing, Customer Service, and Supply Chain teams to ensure alignment with quality requirements.
• Support distributor onboarding activities and annual contractual quality processes.
• Monitor field inventory quality processes and help identify, escalate, and mitigate quality risks.
• Support qualification, evaluation, and ongoing monitoring of third-party suppliers and distributors.
• Manage CAPA investigations, action plans, and timely implementation of corrective and preventive actions.
• Deliver and support quality training initiatives related to inventory, warehousing, and distribution.
• Participate in internal and external audits and support audit readiness across affiliates.
• Assist with the development, implementation, and maintenance of quality procedures and documentation.
• Escalate warehousing, inventory, and distribution-related quality risks to the EMEA QA leadership team.

• Bachelor's Degree in Life Sciences, Engineering, Quality, Supply Chain, or a related discipline, or equivalent professional experience.
• 2-4 years of experience in Quality Assurance, Supply Chain Quality, Warehousing, Distribution Quality, Medical Devices, Pharmaceuticals, or another regulated industry.
• Knowledge of ISO 13485 and Medical Device Regulations.
• Experience working within a Quality Management System (QMS) environment.
• Strong analytical, problem-solving, and investigation skills.
• Experience managing CAPAs and supporting audits.
• Excellent communication and stakeholder management skills.
• Ability to work effectively in a cross-functional and international environment.

Join Abbott and help ensure the highest standards of quality and compliance while supporting life-changing medical technologies that improve the lives of patients across the EMEA region.

In specific locations, the pay range may vary from the range posted.