Abbott

Senior Quality Software Engineer

Abbott$78K — $156K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in computer science, software engineering, or a closely related field; Master's preferred.
  • Minimum 4 years of experience in Quality or a related field.
  • Experience using SBM, Ariba, or similar platforms.
  • Proficiency in Microsoft Suite.
  • Knowledge of FDA regulations, QSR, ISO guidelines, and 21 CFR Part 11.

Responsibilities

  • Review documentation for accuracy, clarity, consistency, and compliance across projects.
  • Analyze data and procedures with a focus on financial and business outcomes.
  • Coordinate activities across impacted groups and take ownership of decisions.
  • Engage and provide guidance to team members and various functions.
  • Apply risk management principles to investigate non-conformances and suggest process improvements.
  • Participate in developing validation packages including risk assessments and protocols.
  • Assist with supplier evaluations to ensure compliance with quality requirements.

Benefits

  • Health and wellness benefits for you and your family.
  • Diverse career opportunities within Abbott.
Full Job Description
JOB DESCRIPTION:

Job Title

Sr. Software Engineer, Quality

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'll 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


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.

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.

JOB FAMILY:
Operations Quality

DIVISION:
AVD Vascular

LOCATION:
United States > Lake Forest : CP01

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 10 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ

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