Sr. Specialist Quality Assurance
Abbott, California, MO, United States
Role
Sr. Specialist Quality Assurance
Responsibilities
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.
Compensation
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.
Apply and Diversity
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.
#J-18808-Ljbffr
Sr. Specialist Quality Assurance
Responsibilities
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.
Compensation
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.
Apply and Diversity
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.
#J-18808-Ljbffr