Software Quality Engineer
*Reports To Sr. Manager IT Process and Compliance FLSA
The software quality engineer will play a key role in the various business system software
implementation and maintenance by driving quality improvements and validating quality
criteria. This role will also have a broad range of responsibilities in project management
1. Reviews software requirements/specifications and provide quality feedback.
2. Collaborate with various departments to create, document and execute
comprehensive tests plans and test cases.
3. Define and validate acceptance criteria.
4. Understand risk-based testing and establish quality goals.
5. Monitor all stages of business system software (implementation, continuous
6. Business system software requirements management owner.
7. Business system software change management owner.
8. Able to perform software configuration based on end user needs.
9. Support audit logistics during inspections.
10. Develop or source out automated testing solutions.
11. Assist in running reports in various applications for correct access and permissions.
12. Back up support for granting access to various business system software.
13. Assist with procedure development.
14. Support for ongoing review of separation of duties for key users/functions.
15. Assist with creating training and other necessary documentation.
16. Provide support for international compliance, where applicable.
17. Work alongside key departments that own key quality systems.
18. Work alongside project managers and departmental leads to evaluate new solutions,
such as upgrades and add-on tools.FM052 Rev. A
1. 3+ years in related role in addition to bachelor’s degree in Information Systems,
Quality Assurance, Software QA, or related field.
2. Experience interpreting large data sets and/or creating data analysis tools.
3. Experience in evaluating, using and/or supporting quality solutions, such as QMS,
PLM, requirements management, training or related systems.
4. Experience with software validation planning and documentation.
5. Experience with medical device manufacturing field.
6. Broad business and/or technical work experience.
7. Ability to translate technical jargon into executive friendly terms.
8. Demonstrate ability to work in a dynamic, collaborative environment.
9. Strong written and oral communication skills, including an ability to articulate ideas
clearly and appropriately influence others.
10. Excellent organizational, interpersonal and teamwork skills.