Engineer, Software Quality

This is an onsite role; remote work is not possible.

Pay: $50-53/hour W2.

W2 candidates only for this role; C2C is not possible.

Description

1. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the Client.
2. Develop and conduct training of company personnel for the divisional software development and validation program.
3. Engineering in the completion of system/software requirements and other verification and validation processes.
4. Create and execute or direct software validation protocols traceable to system/software requirements.
5. Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
6. Assist in the completion and maintenance of risk analysis, focused on software-related risks.
7. Design and implement various product and process improvement methodologies (i.e., Six Sigma and Lean Manufacturing).
8. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
9. Software scoping and Part 11 audits.
10. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
11. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
12. Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications:

1. BS Degree in Engineering or Technical Field or equivalent experience.
2. 2-5 years Software Quality Engineering experience.
3. Detailed knowledge of FDA, GMP, IEEE 1012, and ISO 13485.
4. Advanced computer skills, including statistical/data analysis and report writing.
5. Advanced Information Technology and data mining skills.
6. Prior medical device experience preferred.