Software Quality Engineer Job
About the Role:
We are seeking a skilled Software Quality Engineer to join our team.
The successful candidate will be responsible for ensuring the quality and compliance of software systems used in regulated processes.
Key Responsibilities:
* Lead software validation activities for new and existing systems, ensuring compliance with design control and regulatory requirements.
* Develop and maintain validation documentation (protocols, reports, risk assessments) aligned with FDA, ISO, and applicable guidelines.
* Perform software compliance assessments for regulations such as 21 CFR Part 11, Data Integrity, and applicable GxP guidelines.
* Maintain and improve SOPs and work instructions related to software quality and validation.
* Monitor and report key quality metrics, trends, and continuous improvement initiatives to stakeholders.
* Collaborate with cross-functional teams to ensure robust software lifecycle management from development through deployment.
Requirements:
Applicants must have a degree in IT, Engineering, Science, or a related discipline and 4–5 years of experience in software validation or compliance within a medical device or regulated healthcare environment.
Benefits:
Working in a dynamic environment where innovation meets compliance, ensuring patient safety and product quality worldwide.
Why Choose This Role?
This is an opportunity to set the standard for software quality excellence in healthcare technology and contribute to shaping the future of our industry.