Abbott

Principle Professional Quality

Abbott • $99K — $198K *
Lake Forest, IL 60045In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Associate's degree in engineering, quality assurance, or a related field.
  • 3+ years of experience in quality assurance or quality control, ideally in regulated environments.
  • Preferred experience with ISO 9001 and ISO 27001 quality systems.
  • Knowledge of agile development and risk management processes.

Responsibilities

  • Serve as a quality expert for digital health solutions.
  • Lead quality assurance throughout the product lifecycle.
  • Collaborate with cross-functional teams to integrate quality standards.
  • Support post-market surveillance and customer feedback analyses.
  • Oversee quality system processes like document control and audits.
  • Maintain and improve certified quality management systems.
  • Provide quality oversight for suppliers and contractors.

Benefits

  • Access to comprehensive health and wellness benefits.
  • Work for a company offering diverse career opportunities.
  • Support for work-life balance with flexible environments.
Full Job Description
JOB DESCRIPTION:

The Opportunity
This position works out of our Lake Forest, IL location in the Core Lab, 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 Principal Professional Quality is responsible for the implementation and management of the Quality Assurance program for the Core Dx Digital Health Solution products. The role includes oversight of design and development quality processes, post-market support, and continuous improvement initiatives. The Principle Professional Quality position ensures that product quality and information security standards meet or exceed internal and external requirements and maintains the standard of excellence established by the Core Dx division.

What You'll Work On
  • Serve as a quality subject matter expert for digital health solutions, providing guidance on quality, compliance, risk management, and software development best practices.
  • Lead quality assurance efforts throughout the product lifecycle, including design reviews, risk assessments, verification and validation activities, change control, and product release.
  • Collaborate with engineering, product management, and IT teams to ensure quality and security requirements are effectively integrated into design, development, and maintenance processes.
  • Support post-market surveillance and customer feedback analysis to drive product improvements and ensure continued compliance.
  • Oversee key quality system processes, including document control, nonconformance and CAPA management, and internal audits related to both product quality and information security.
  • Maintain and continuously improve certified quality management system (ISO 9001, ISO 27001, etc.), ensuring alignment to divisional, corporate, and external requirements.
  • Provide quality oversight of suppliers, contractors, and service providers to ensure compliance with established quality and information security requirements.
  • Support and facilitate external and internal audits, certification assessments, customer audits, and regulatory inspections, ensuring organizational readiness and effective resolution of observations.
  • Collaborate with global quality teams and technical teams in United States, Portugal, and Italy to drive harmonization, consistency, and continuous improvement across quality processes.
  • May serve as the Management Representative for the Quality System; acts as a point of contact providing quality guidance and expertise for digital products to represent the organization as the main interface with necessary regulatory bodies and external auditors.


Required Qualifications
  • Associate's degree in engineering, quality assurance, or a related technical field.
  • Minimum 3+ years of experience in quality assurance or quality control, preferably in product development, regulated environments, non-medical products, or digital health.
  • Experience with ISO 9001 and ISO 27001 quality systems preferred.
  • Familiarity with agile development, design control, risk management, and post-market surveillance processes.


Preferred Qualifications
  • Bachelor's degree in Software Engineering, Computer Science, Quality Engineering, Biomedical Engineering, Information Systems, or a related technical discipline.
  • 6+ years of progressive Quality Assurance experience supporting software, digital health, diagnostics, medical devices, or other regulated product environments.
  • Demonstrated ability to lead design reviews, risk assessments, root cause investigations, CAPA activities, and supplier quality management.
  • Knowledge of software development methodologies, including Agile and Scrum, with familiarity in cybersecurity and information security principles, risk management frameworks, secure software development practices, and information security controls.
  • Proven ability to independently manage multiple priorities, lead complex quality initiatives, and deliver results in a fast-paced, global environment with cross-functional teams, including engineering, product management, marketing, regulatory affairs, IT, cybersecurity, and suppliers.
  • Strong communication, organizational, and problem-solving skills, with the ability to influence stakeholders and drive continuous improvement.


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
$99,300.00 - $198,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
CRLB Core Lab

LOCATION:
United States > Lake Forest : CP01

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 10 % 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

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Abbott

More Pharmaceuticals & Biotech Jobs

Find similar Principle Professional Quality jobs:

NationwideLake Forest, IL