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The Quality Assurance Specialist 3 is responsible for overseeing supplier quality activities to ensure materials, components, and services used in medical device manufacturing consistently meet established quality and regulatory standards. The role supports compliance with applicable quality systems through supplier performance monitoring, risk assessment, corrective action management, and supplier control processes.
Job Responsibility
Manage supplier qualification, monitoring, and periodic re-evaluation activities
Monitor supplier quality performance using key quality metrics and trends
Maintain Approved Supplier Lists (ASL) and supplier quality documentation
Review, track, and assess supplier change requests and their impact on product quality and compliance
Escalate supplier quality concerns and support corrective and preventive actions
Collaborate with Engineering and Regulatory teams to evaluate supplier changes requiring validation or regulatory assessment
Contribute supplier quality data and insights for management reviews
Ensure supplier records are accurate and maintained within the electronic Quality Management System (eQMS)
Verify supplier activities comply with internal procedures and quality system requirements
Requirements
2–5 years of experience in Supplier Quality, Quality Assurance, or Manufacturing within the medical device industry or another regulated environment
Experience working with supplier controls, quality systems, and cross-functional teams
Knowledge of FDA Quality System requirements and ISO 13485 standards
Supplier quality management and performance monitoring
Risk assessment and problem-solving abilities
Proficiency in Microsoft Excel and data analysis
Strong written and verbal communication skills
Ability to influence stakeholders and collaborate across departments
Excellent organizational and time-management skills
High attention to detail and analytical mindset
Bachelor's degree in Engineering, Quality, or a related discipline
Working knowledge of supplier control requirements and regulated quality systems