Senior Quality Software Engineer

Abbott; Lake Forest (IL); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott, a global healthcare leader, is seeking a Sr. Software Engineer, Quality for an on-site role across Abbott locations in the United States.

The candidate will review documentation, analyze data, and coordinate activities across teams to ensure quality across projects.

Qualifications

• Bachelor's Degree in computer science, software engineering, or a closely related discipline or an equivalent combination of education and work experience. Master’s degree preferred.
• Minimum 4 years related work experience in Quality or a related field.
• Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11.
• Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices or experience leading test engineer team is a plus.

Responsibilities

• Reviews pre-defined deliverables/activities as identified in SWQA Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
• Applies basic 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 validation packages and deliverables, including assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.
• Ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems.
• Assists with supplier assessments and evaluations to assure products and services meet quality requirements. May evaluate vendor capabilities to provide required products or services.

Skills

Quality assurance

Testing

Documentation review

Education

Bachelor's Degree in computer science or software engineering

Master’s degree preferred

Tools

SBM

Ariba

MS Suite

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 Title

Sr. Software Engineer, Quality

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 of which you dream.
• 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.

The Opportunity

We are seeking a Sr. Software Engineer, Quality. This role can be in any of our Abbott location in the United States. This is an onsite role.

MAIN PURPOSE OF ROLE

• Reviews documentation for accuracy, clarity, consistency, completeness and compliance for multiple projects. Plans and performs assignments with a wide degree of difficulty.
• Analyzes data, procedures, and requirements with consideration given to financial and business outcomes.
• Coordinates activities across impacted groups. Accepts ownership and responsibility for decisions.
• Effectively engages team members and provides guidance to various functions, other professionals, and technicians.

Main Responsibilities

• Reviews pre-defined deliverables/activities as identified in software quality assurance (SWQA) Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
• Applies basic 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 validation packages and deliverables, including, assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.
• Ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems.
• Assists with supplier assessments and evaluations to assure products and services meet quality requirements. May evaluate vendor capabilities to provide required products or services.

Education and Experience You’'l Bring

Education Level

• Bachelor's Degree in computer science, software engineering, or a closely related discipline or an equivalent combination of education and work experience. Master’s degree preferred

Experience/Background Experience

• Minimum 4 years related work experience in Quality or a related field.
• SBM, Ariba or similar platform
• MS Suite
• Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11.
• Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices or experience leading test engineer team is a plus

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.