Bachelor's degree in software engineering or related field
Three years of relevant software testing experience
Knowledge of fda regulations and quality management systems
This role involves performing software verification activities and supporting testing for system hardware, software, and test data manipulation projects within the medical device industry
Job Summary
This role involves performing software verification activities and supporting testing for system hardware, software, and test data manipulation projects within the medical device industry.
The successful candidate will ensure adherence to Quality Management Systems (QMS), FDA regulations, and safety requirements while conducting failure analysis and process improvements.
Candidates must demonstrate the ability to work independently with occasional guidance, collaborate across functional teams, and maintain a calm demeanor in a fast-paced production environment.
Matching Summary
This role involves performing software verification activities and supporting testing for system hardware, software, and test data manipulation projects within the medical device industry.
Skills & Requirements
Must-have
Bachelor's degree in Software Engineering or related field
Three years of relevant software testing experience
Knowledge of FDA regulations and Quality Management Systems
Experience with root cause analysis and failure investigation
Ability to develop and execute software test plans
Nice-to-have
Proactive insight into technical challenges
Strong written and oral communication skills
Positive can-do attitude in high-energy environments
Familiarity with Integer Production System methodologies
Experience with continuous improvement initiatives
Key Requirements
Minimum Bachelor's degree in Software Engineering or related technical field
At least three years of relevant experience in software testing
Functional understanding of Quality Management Systems (QMS)