Quality Engineer

Job Description : Responsibilities :

• CAPA Management : Lead and support Corrective and Preventive Action (CAPA) investigations, including root cause analysis, action implementation, and effectiveness verification.
• Nonconformance (Client) Handling : Review and process NCRs, coordinate cross-functional resolution efforts, and ensure timely closure in compliance with quality procedures.
• Receiving Inspection : Perform inspections of incoming materials and components to verify conformance to specifications and regulatory requirements. Maintain inspection records and collaborate with suppliers on quality issues.
• Quality System Support : Assist in internal and external audits, maintain documentation for ISO 13485 and FDA QSR compliance, and support quality system improvements.
• Data Analysis & Reporting : Analyze quality data, prepare reports on trends and metrics, and recommend improvements to enhance product quality and process efficiency.

Skills :

Education / Experience :

J-18808-Ljbffr