Abbott
Software Quality Engineer - Senior or Lead
Abbott, Irving, Texas, United States, 75084
Title: Software Quality Engineer - Senior or Lead
Location: Irving, TX
Duration: 12 Months Contract
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.
Key Responsbilities: 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. Qualifications:
BS degree in Engineering or Technical Field or equivalent experience. 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. Ability to travel approximately 5-25%, including internationally. Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
Published on 05 Nov 2024, 8:31 PM
Location: Irving, TX
Duration: 12 Months Contract
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.
Key Responsbilities: 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. Qualifications:
BS degree in Engineering or Technical Field or equivalent experience. 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. Ability to travel approximately 5-25%, including internationally. Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
Published on 05 Nov 2024, 8:31 PM