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Veterans at Abbott

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Abbott Senior Software Validation Quality Engineer in Liberty, South Carolina

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, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division.

Main 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 (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.

  • Performs other related duties and responsibilities, on occasion, as assigned.

Additional Responsibilities may include:

  • Develop of procedures and standards.

  • Assist in audit.

  • Project Management

  • Recognize risks versus the relative gains associated with actions; understand projects.

  • Responsible to meeting established objectives and goals.

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

  • 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 approximately 5-25%, including internationally.

  • Ability to maintain regular and predictable attendance.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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