Software Quality, Engineer I

4 weeks ago

Sylmar, United States Abbott Laboratories Full time

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

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. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of .

  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

  • 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 bachelorâs 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.

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 non-product software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures..

What Youâll Work On

  • Provide support for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance for the same.

  • Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.

  • Participate in reviews for Non-product System and 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 (manual and automated), test scripts (manual and automated), test reports

  • 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.

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

  • Support internal (corporate and divisional) and external quality audit

  • 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.

  • May liaise with external vendors.

  • 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.

EDUCATION AND EXPERIENCE YOUâLL 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.

  • 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.

 

Preferred Qualifications :

  • Degree in Engineering or Technical Field, Electrical/Computer Engineering preferred

  • 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 is a plus.

  • 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. ASQ CSQE certification desired.

  • 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.

 

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.



The base pay for this position is $55,200.00 â $110,400.00. In specific locations, the pay range may vary from the range posted.

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