Senior Software Quality Assurance Engineer

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:
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers - such as glucose, ketones, and lactate - to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.
Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.
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 .
• 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 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.

This Senior Software Quality Assurance Engineerposition works out of Alameda, CA location.
As a Senior Software Quality Assurance Engineer, you will ensure that product software and computerized systems used in the support of the Quality System are developed, validated, and maintained in compliance with applicable regulatory and corporate requirements. Participate as a member of the project team for Lingo products that incorporate software/firmware into their system. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of the software or firmware. Coordinate activities with other engineering disciplines, departments and contractors. Estimate, plan and review own and others' work products.
What you'll do

• Completes SWQA tasks in accordance with current Quality System Requirements.
• Works independently with objectives given by SWQA Manager or QA Director.
• Can plan and coordinate own work according to higher-level project schedules.
• Reviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
• Ensure documentation accuracy, clarity, consistency, completeness, and compliance for multiple projects. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports.
• Report unexpected events, issues or software bugs which occur during verification/validation to project team and management.
• Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of computerized systems used in the Quality System as well as those used in the development of ADC Abbott and Lingo software/firmware products.
• Ensures that appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems.
• May Develop and maintain Validation Master Plan(s).
• May have responsibilities to monitor and direct the work of contractors/temporaries.
• Ensure that Abbott and Lingo computerized systems used in the support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements.
• Ensure that deliverables and activities are in compliance with current Software/SWQA processes in the development of Lingo software/firmware products.

Qualifications

• Bachelors degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• Minimum 4 years of experience in Software Quality Assurance.
• Knowledge of FDA QSR, ISO guidelines and 21 CFR Part 11.
• knowledge of Design Control requirements and software development lifecycle
• Must have 2 - 4 years project experience in software testing practices, methodologies and techniques, preferably in testing medical devices.
• Must have excellent oral and written communication skills.

Preferred Qualifications

• Experience working in consumer product software strongly preferred
• Experience working in mobile application products preferred
• Experience leading test engineer team
• Knowledge of Jira, Confluence, ALM Quality Center, and/or other software development and test tools
• Software development experience a plus
• ASQ Certifications

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
$82,100.00 - $164,100.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
LNGO Lingo
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
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.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf