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Software Quality Assurance Engineer

1 month ago

Irving, Texas, United States Mindlance Full time
Job Summary:

This is a non-exempt position responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout Client. The successful candidate will have a strong background in software quality assurance and a proven track record of delivering high-quality results.

Key Responsibilities:

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 (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.

Requirements:

BS Degree in Engineering or Technical Field or equivalent experience.
2-5 years Software Quality Engineering experience.
Detailed knowledge of FDA, GMP, IEEE 1012, and ISO.
Advanced computer skills, including statistical/data analysis and report writing.
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.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes, and meets deadlines in a timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel, including internationally.
Ability to maintain regular and predictable attendance.

EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."