Sr. Specialist Quality Assurance

Sr. Specialist Quality Assurance

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

• Participates as a member of the Non-Product Software Quality Assurance (SWQA) team for Abbott Diabetes Care. 

• Ensures systems / applications produced in support of the Quality System or consumer products are developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. 

• Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software or systems /applications in support of the Quality System. 

• 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 Management.
• 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.
• Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management. Assists subordinate staff in recognizing the same.
• 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.
• Supports ADC Non-Product Software Lifecycle process improvement initiatives.

Required Qualifications

• Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.  
• Min 5 years’ experience in Software Quality Assurance and Software Testing experience.  
• Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.
• Must have 2-5 years project experience across the software lifecycle, including methodologies such as Agile and associated techniques; experience with medical devices and mobile applications is preferred.
• Must have excellent oral and written communication skills.  
• ASQ Certifications a plus.

Preferred Qualifications

• Medical Device and AI experience are strongly preferred. 
• Cybersecurity or cloud computing experience preferred. 

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.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Diabetes

We’re 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 base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.

• software quality assurance
• fda qsr
• software testing
• iso 13485
• 21 cfr part 11
• iso 14971
• design control
• agile methodologies
• verification and validation
• medical device software
• trace matrices
• project coordination
• mobile applications
• cybersecurity
• cloud computing