Support the execution of site quality compliance programs to ensure site adherence to AbbVie Policies, and current Good manufacturing practices (cGMP) requirements per regulatory standards.
Develop, modify, apply, and maintain quality standards and protocols for transferring products and manufacturing processes, ensuring compliance with ISO 13485:2016 and the company’s Quality Management System (QMS).
The Quality Engineer is responsible for leading sustaining quality activities and supporting new product transfers by ensuring manufacturing processes are capable, compliant, and deliver consistent product quality. The role focuses on process validation, risk management, regulatory compliance, and continuous improvement while supporting production and meeting customer quality expectations.
The Quality Engineer is responsible for leading sustaining quality activities and supporting new product transfers by ensuring manufacturing processes are capable, compliant, and deliver consistent product quality. The role focuses on process validation, risk management, regulatory compliance, and continuous improvement while supporting production and meeting customer quality expectations.
Support the implementation, maintenance, and continual improvement of the Integrated Management System (IMS) covering ISO 9001, ISO 41001, ISO 22301, and ISO 27001.
Conduct quality check for incoming parts against drawings by performing visual, mechanical and functional check on components and record the findings in the Receiving Inspection Instruction form