Quality Assurance Specialist
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Job Description
Quality Assurance Specialist supporting Abbott’s medical-device warehousing, inventory, and distribution compliance across EMEA. Managing QMS, CAPA, supplier, distributor, and audit activities.
Responsibilities:
- Implement and maintain Quality Assurance requirements for warehousing, inventory, and distribution activities across EMEA
- Support 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 identify, escalate, and mitigate quality risks
- Support qualification, evaluation, and ongoing monitoring of third-party suppliers and distributors
- Manage CAPA investigations, action plans, and 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 quality procedures and documentation
- Escalate quality risks to the EMEA QA leadership team
Requirements:
- 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
Benefits:
- Career development with an international company
- Access to a company recognized as a great place to work in dozens of countries
- Work at a company recognized as one of the best big companies to work for and a best place to work for diversity, working mothers, female executives, and scientists
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