Engineer Software Quality
2 weeks ago
Engineer, Software Quality
Irving, TX
12+ month’s contract
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 (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.
· Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485.
· 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 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.
Company DescriptionAbout Kyyba:Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.Company DescriptionAbout Kyyba:\r
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.\r
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
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