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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
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. 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.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
MAIN PURPOSE OF ROLE
- This will be an ONSITE role, based out of Sylmar, CA.
- We are seeking a high caliber Software Quality Engineer I supporting the DevOps and Non-Product Software 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, validating and maintaining software tools, supporting and troubleshooting applications.
MAIN RESPONSIBILITIES
- 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.
- Provide support for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance to relevant FDA QSR, ISO guidelines, 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).
- Support internal (corporate and divisional) and external quality audit
- Apply quality principles, analyzes quality records, prepares reports and recommends improvements.
- 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.
- Bachelors Degree (± 16 years) in Computer Engineering or a related field.
Experience/Background
- Minimum 1 year of relevant experience.
- Software Quality Engineering experience
- Prior medical device experience preferred.
- 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.
Experience/Knowledge:
- 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
- Networkin
Tools/Technologies:
- Jfrog Artifactory, Git, Jira, Bitbucket, REST API, Markdown, AZ CLI, Docker CLI, KubeCTL, Linux, Windows, Firewall, IOTHub, PostgreSQL, Active MQ, Azure Kubernetes
- 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
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.
The base pay for this position is
$73,900.00 – $116,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
CRM Cardiac Rhythm Management
LOCATION:
United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
