Role: Software Quality - Senior or Lead Engineer

Location: Irving, TX - 75038

Duration: 11 Months

Job Description:

• This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division.
• Duties: 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 validation 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 (ie 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.
• BS degree in Engineering or Technical Field or equivalent experience.
• Qualifications: At least 7 years Software Quality Engineering experience.
• Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Advanced Information Technology and data mining skills.
• Prior medical device experience preferred.
• ASQ CSQE certification desired.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.