Principle Professional Quality

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 115000 colleagues serve people in more than 160 countries.

Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.

• 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 a high employer contribution.

• Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.

• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity working mothers female executives and scientists.

The Opportunity
This position works out of our Lake Forest IL location in the Core Lab Diagnostics Division. Were 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 Abbotts 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 Youll 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

• Associates 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

• Bachelors 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.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

$99300.00 $198700.00

In specific locations the pay range may vary from the range posted.

Operations Quality

CRLB Core Lab

United States > Lake Forest : CP01

Standard

Yes 10 % of the Time

Not Applicable

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)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Unclear Seniority