Abbott

Senior Quality Assurance Engineer, Non-Product Software Validation

Abbott • $78K — $156K *
Lake Forest, IL 60045In-Person
Healthcare
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Computer Science, Software Engineering, or related field; Master's preferred.
  • Minimum 4 years of experience in Quality or a related field.
  • Familiar with FDA, Quality System Regulations (QSR), ISO guidelines, and 21 CFR Part 11.
  • Knowledge of software quality engineering principles and practices.
  • Experience in software testing methodologies, particularly for medical devices is advantageous.

Responsibilities

  • Implement and maintain the quality system's effectiveness.
  • Investigate and solve software quality problems using established engineering methods.
  • Advise project management on quality aspects of software projects.
  • Create and improve software development and quality operating procedures.
  • Lead efforts to enhance software development and quality practices.
  • Collaborate with management and external entities on quality issues and process improvements.
  • Review predetermined deliverables and activities as part of the quality assurance process.
  • Conduct risk assessments and identify areas for process improvement through non-conformance investigations.

Benefits

  • Comprehensive health and wellness benefits for employees and families.
  • Diverse opportunities for career growth within Abbott.
  • Supportive work environment fostering professional development.
Full Job Description
JOB DESCRIPTION:

The Opportunity
This position works out of our Lake Forest, IL location in the Transfusion Medicine, Diagnostics Division. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

The Senior Quality Assurance Engineer, Non-Product Software Validation, is responsible for compliance with the non-product software Life Cycle supporting applications used throughout ADD. Uses software quality engineering principles to recommend unique tailoring approaches to allow the project to both meet its Software Life Cycle requirements and improve its development efficiency.

What You'll Work On
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Apply established software quality and engineering methods to the investigation and solution of software quality problems.
  • Advises project management and participates in the quality aspects of software projects.
  • Helps in the creation and improvement of software development and quality operating procedures.
  • May lead in the creation and improvement of software development and quality operating procedures.
  • Deals with mid-level management and outside entities in response to quality problems, needed process improvement, and audit observations.
  • 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.
  • Apply 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 with 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 ensure products and services meet quality requirements. May evaluate vendor capabilities to provide required products or services.


Required Qualifications
  • Bachelors 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.


Preferred Qualifications
  • 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: https://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:
TM Transfusion Medicine

LOCATION:
United States > Lake Forest : CP01

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

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
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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