Senior Quality Assurance Engineer II
Core
Ensures product quality and compliance for medical devices through risk management, supplier audits, nonconformance analysis, and quality system maintenance.
Role type
Senior Quality Assurance Engineer (Medical Devices)
Builds
Verification, validation, monitoring, and inspection methods, procedures, and test protocols for assigned product lines.
Domain
Medical Devices / Regulatory Compliance
Required skills
Risk management, Supplier quality audits, Nonconformance record analysis, Corrective and preventive actions (CAPA), Quality management system maintenance, Statistical methodologies, Lean manufacturing, Six Sigma, Engineering techniques evaluation
Preferred skills
SmartCAPA, Oracle, Crystal Reports, Deviation handling, Investigations
Technologies
SmartCAPA, Oracle, Crystal Reports
Responsibilities
Evaluate and select engineering techniques and criteria; Review and approve Engineering Change Notifications (ECNs); Monitor supplier performance and conduct quality audits; Review nonconformance records to determine root cause and corrective actions; Ensure containment of nonconforming product; Identify changes to maintain quality management system effectiveness; Evaluate manufacturing work environment controls.
Seniority
Senior, hands-on IC