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Software Quality, Engineer II

2 months ago

Sylmar, United States Abbott Laboratories Full time

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 114,000 colleagues serve people in more than 160 countries.

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 II supporting the DevOps functions. Working under general supervision, provides quality oversight to development and production operation activities including, but not limited to, planning, and coordinating software deployment, implementation of various services involving on-prem and Cloud, developing and maintaining software tools, supporting and troubleshooting applications. You will be working on various Cloud services and  also provide quality oversight to our existing operations hosted on-prem which includes managing several java applications, support middleware technologies, continuous automation, adapt Site reliability engineering (SRE) principles to operations problems and drive quality, compliance, security initiatives.

What Youâll Work On

  • Has good understanding of the software programming, agile software development, database management, networking concepts, cybersecurity, and cloud computing.

  • Supports deployment of CI/CD pipelines and demonstrate scripting skills through Ruby, Python, Shell or other scripting languages.

  • Supports release and deployment of code from Development, Test, Stage and Production environments

  • Applies risk management principles to all activities and tasks to investigate non-conformances. Identifies areas for process improvement and provides supporting information for change, including reasons and justifications.

  • Participates in the development or modification of verification/validation packages and deliverables, including, assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.

  • Ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems.

  • 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.

  • 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.

  • 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.

  • 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 Engineering or Technical Field (Electrical/Computer Engineering preferred) or an equivalent combination of education and work experience

  • Minimum 2 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(only if required).

 

Preferred Qualifications :

  • Prior medical device experience preferred.

  • Agile development process

  • System design best practices

  • Jenkins pipeline design

  • Pipeline unit testing

  • Object oriented programming e.g. C/C++/C#

  • Scripting languages e.g. Python

  • Containerization

  • Networking

  • Tools/Technologies: Jfrog Artifactory, Git, Jira, Bitbucket, REST API, Markdown, AZ CLI, Docker CLI, KubeCTL, Linux, Windows, Firewall, IOTHub, PostgreSQL, Active MQ, Azure Kubernetes

  • Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles.

  • 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.

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 $65,900.00 â $131,900.00. In specific locations, the pay range may vary from the range posted.