Job Description
Job Title: Quality Engineer IJob Description
The Quality Engineer I supports quality operations in a regulated manufacturing environment and ensures compliance with FDA and ISO standards. This role focuses heavily on owning CAPA activities, managing non-conformances, and executing day-to-day quality system processes. The position also contributes to cross-functional projects, process validation, risk management, and continuous improvement initiatives across Manufacturing, R&D, and Quality teams.
Responsibilities
+ Lead CAPA investigations from initiation through closure, including root cause analysis, corrective and preventive action planning, and effectiveness verification.
+ Review, manage, and maintain non-conformance records and other quality records, including equipment-related incidents, ensuring timely and compliant documentation.
+ Support daily quality operations in a fast-paced manufacturing environment, addressing issues in real time and ensu...
The Quality Engineer I supports quality operations in a regulated manufacturing environment and ensures compliance with FDA and ISO standards. This role focuses heavily on owning CAPA activities, managing non-conformances, and executing day-to-day quality system processes. The position also contributes to cross-functional projects, process validation, risk management, and continuous improvement initiatives across Manufacturing, R&D, and Quality teams.
Responsibilities
+ Lead CAPA investigations from initiation through closure, including root cause analysis, corrective and preventive action planning, and effectiveness verification.
+ Review, manage, and maintain non-conformance records and other quality records, including equipment-related incidents, ensuring timely and compliant documentation.
+ Support daily quality operations in a fast-paced manufacturing environment, addressing issues in real time and ensu...