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Software Quality Engineer
3 weeks ago
Client: Medical Device Client
Role: Software Quality Engineer
Location: 387 Technology Circle NW Suite 500, Atlanta, GA 30313
Tax Terms: W2 Only
Role:
- Develop and conduct training of company personnel for the divisional software development and validation program. Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validatiton processes.
- Create and execute or direct software validation protocols traceable to system/software requirements. Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. Assist in the completion and maintenance of risk analysis, focused on software related risks.
- Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing). Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues. Software scoping and Part 11 audits.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned.
- Qualifications: BS Degree in Engineering or Technical Field or equivalent experience. 2-5 years Software Quality Engineering experience.
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