Location: 675 N Field Dr, Lake Forest, IL 60045, USA (ONSITE)
Working hours: 8:30AM - 4:30PM, Monday through Friday
Description:
This is a non-exempt position. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout Abbott.
Duties: 
*	Develop and conduct training of company personnel for the divisional software development and validation program.
*	Work with Design and NManufacturing 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.
*	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.
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Software Engineer

CAREER OPPORTUNITY FOR YOU! - SOFTWARE QUALITY ENGINEER - URGENT!!
