Software QA Engineer Level III
Alameda, USA
Job description
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:
About Abbott
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.
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.
· 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.
The Opportunity
This position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
The Software Quality Engineer Level III participates as a member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications, firmware, and QMS produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. They will review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software and/or QMS. This person will also coordinate activities with other engineering disciplines, departments, and contractors.
What you’ll work on
· Completes software quality tasks in accordance with current Quality System Requirements.
· Works independently with objectives given by SWQA Manager.
· Can plan and coordinate own work according to higher-level project schedules.
· Reviews deliverables/activities as identified in the ADC Design Control Process/project plan or equivalent project plan. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site.
· Collaborate on unexpected events, issues or software bugs which occur during verification/validation to project team and management.
· Ensures compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of medical device software.
Required Qualifications
· Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
· 2 to 5 years’ experience in Software Quality Assurance and/or Software Testing experience.
· Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.
· Must have 1 - 3 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices and mobile applications.
· Must have excellent oral and written communication skills.
Preferred Qualifications
· ASQ Certifications a plus.
· Medical Device experience strongly preferred.
· Cyber security, medical mobile applications or cloud computing experience preferred.
What We Offer
At Abbott, you can have a good job that can grow into a great career. We offer:
· Training and career development , with onboarding programs for new employees and tuition assistance
· Financial security through competitive compensation, incentives and retirement plans
· Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
· Paid time off
· 401(k) retirement savings with a generous company match
· The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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
$83,600.00 – $167,200.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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