Software Quality Engineer I

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.

The Opportunity

This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

We are seeking a high caliber Software Quality Engineer I. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. Work requires the application of theoretical engineering principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of specialized study. Applies engineering and scientific principles to the evaluation and solution of technical problems in a creative manner unique to each project. Exercises level appropriate technical judgment in planning, organizing, performing, and/or coordinating engineering work.

What You’ll Work On

• 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 and reports traceable to system/software requirements. Execute and support on-time completion of Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports.

• Review and approve Non-Product Software (NPS) assessment, Data Integrity assessments and Risk Analysis assessment to comply with FDA 21 CFR Part 11.

• Participate in reviews for Software requirements with ability to interpret and review system design (hardware, firmware, software) and provide useful feedback.

• 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.

• Support cybersecurity assessments with cross functional team

• Follow approved Design Control procedures for software development in accordance with FDA guidelines.

• Contributes to and supports a variety of test phase efforts.

• Support the establishment of objective, measurable, and verifiable customer and product requirements

• Reviews project deliverables such as specifications, code, and test/tool procedures for feasibility, thoroughness, clarity, correctness, and accuracy.

• Bring forth ideas and implement quality tools that improve the software design reviews and software testing lifecycle

• Apply quality principles, analyzes quality records, prepares reports and recommends improvements.

• 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.

• Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.

• Document quality issues and performance measures for management review.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelors Degree OR an equivalent combination of education and work experience Experience/Background Experience Experience Details

• 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.

Apply Now

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Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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