Senior Specialist Quality Assurance - (Supplier Quality)
Core
Lead Supplier Quality Management process improvements, including supplier change notifications, CAPA activities, new product introduction support, quality audits, and complaint investigations for Abbott's diagnostics division.
Role type
Senior Specialist Quality Assurance (Supplier Quality)
Builds
Approved supplier base and quality compliance for medical diagnostics instruments
Domain
Medical devices / Diagnostics / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier quality system assessments, supplier performance monitoring, corrective action and preventive action (CAPA), quality audits, complaint investigations, supplier metrics analysis, complex problem analysis, risk identification and quantification, regulatory compliance, project management, database management
Preferred skills
ISO 13485 knowledge, US and non-US Quality System Requirements, audit and inspection experience, quality management techniques, statistical analysis, influence without direct authority
Technologies
Various databases, computer software
Responsibilities
Lead cross-functional supplier quality process improvements, independently resolve complex quality issues, complete documentation in accordance with business standards, travel domestically to support supplier management, ensure compliance with EHS policies
Seniority
Senior, hands-on IC