Job Description
The Senior Software Quality Engineer is accountable for supporting site operations, project teams and other initiatives to enhance operational effectiveness. This includes creating a quality management system, designing processes and procedures that support control, validation, supplier management and technology transfer.
This role focuses on developing quality assurance strategies to ensure software products meet customer expectations. The engineer guides computer system validation efforts, assesses compliance with electronic records regulations and oversees key quality processes such as design planning, risk management and change control.
Main Responsibilities:
* Developing and maintaining strategies to improve overall software quality
* Providing strategic support of the Quality Engineering Function based on industry standards
* Owning the Design Review Process for software products
* Collaborating with Manufacturing and R&D teams to drive design improvements