Software Quality Engineer I

Abbott Laboratories-posted 4 months ago
$72,100 - $114,700/Yr
Full-time • Entry Level
Los Angeles, CA
Miscellaneous Manufacturing
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Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. Working at Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

  • Work with R&D in the completion of system/software requirements and other verification and validation processes related to embedded software products.
  • Participate in reviews for Software requirements with ability to interpret and review system design (hardware, firmware, software) and provide useful feedback.
  • Create and execute or direct software validation protocols traceable to system/software requirements.
  • Execute and support on-time completion of Quality Engineering deliverables: test plans, test scripts (manual and automated), test reports.
  • Identify parameters, structure, and critical test components.
  • Write, update, or execute test design, cases, as well as procedures and reports results.
  • 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 including cybersecurity and data integrity risks.
  • Follow approved Design Control procedures for software development in accordance with FDA guidelines.
  • Contribute to and support root-cause analysis of failures.
  • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues.
  • Support internal (corporate and divisional) and external quality audit.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Readily adjust priorities and work within team environment for timely completion of common objectives for multiple projects.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Bachelor's Degree OR an equivalent combination of education and work experience.
  • Entry level position in which 0-2 years of experience is typical to meet the skills and responsibilities of the position.
  • Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices Preferred.
  • Knowledge of ISO 13485 standard.
  • Knowledge of quality management techniques and application.
  • Ability to clearly, concisely and accurately convey communications.
  • Ability to form and develop interpersonal, professional relationships.
  • Display socially and professionally appropriate behavior.
  • Ability to work independently and in groups.
  • Ability to work cross-functionally.
  • Demonstrated initiative and problem-solving skills.
  • Critical-thinking skills.
  • Ability or aptitude to use various types of databases and other computer software.
  • Strong organizational skills.
  • Ability to prioritize.
  • Ability to multitask.
  • Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.
  • Ability to quickly gain knowledge, understanding or skills and is willing to learn.
  • Electrical/Computer Engineering.
  • Software Quality Engineering experience.
  • Prior medical device experience preferred.
  • Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles preferred.
  • Experience in Bluetooth enabled systems, firmware or embedded software testing and verification/validation preferred.
  • Programming experience in C/C++/C#, Scripting Language such as Python.
  • Experience with software configuration, and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla.
  • Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304 and ISO 13485.
  • Advanced computer skills, including statistical/data analysis and report writing.
  • Advanced Information Technology and data mining skills.
  • Free medical coverage in our Health Investment Plan (HIP) PPO medical plan.
  • Excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement.
  • Freedom 2 Save student debt program.
  • FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
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