Job description

Required:

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 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.

Interview:

• Phone interview followed by WebEx meeting/On-site meeting

Job Types: Full-time, Contract

Pay: $50.00 - $52.00 per hour

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• Software Quality Engineering: 3 years (Required)
• FDA, GMP: 1 year (Required)
• IEEE 1012 and ISO 13485: 1 year (Required)
• Information Technology and data mining: 1 year (Required)

License/Certification:

• ASQ CSQE (Required)

Work Location: One location

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