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Quality Professional

Abbott

Abbott Park, ILJob$68–136K/yrSeen 2w agoSeen in employer's feed today

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At a glance

Compensation
$68–136K/yr
Location
Abbott Park, IL
Work Authorization
Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Quality Professional will analyze quality standards for components, materials, or services, applying measures, sampling methods, testing methodology and other procedures to ensure standards are met.

Skills & qualifications

RequiredNice to have

Skills

Risk ManagementFDA RegulationsQuality System RegulationsMedical Device DirectiveISO Guidelines21 CFR Part 11

Qualifications

Bachelor’s Degree in Life Science or Engineering or Related DisciplineAt Least 3 Years Work Experience in Quality or Related FieldDemonstrate Understanding of How Their Function Supports the BusinessDemonstrates Technical and Business Competencies That Drive Results and Continuous ImprovementKnowledgeable of FDA Quality System Regulations Medical Device Directive ISO Guidelines and 21 CFR Part 11

Benefits

Medical Insurance
401(k) Match
Tuition Assistance

Full 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 122,000 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. You’ll also have access to:

The Opportunity

This position works out of our Abbott Park (Lake Bluff, 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 Quality Professional will analyze quality standards for components, materials, or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.

What You’ll Work On

  • Design/Change Control - Participating in the development & review of all design input, risk management, design verification, design validation, and design output/transfer related design change activity.

  • Risk Management – Understands and applies basic Risk Management principles. Participate in the development and/or modification of Risk Management Files, FMEA’s, etc.

  • Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records with a focus on assay and commodities.

  • Documentation - Reviews documentation for accuracy, clarity, consistency, completeness, and compliance for projects that vary from low to high complexity. Plans and perform assignments with a wide degree of difficulty.

  • Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance with site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.

  • Quality Engineering – May participate on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.

  • Apply quality principles, analyze quality records, prepare reports, and recommend improvements.

  • Conduct inspection, verification and validation of components or materials used in development processes.

  • Document quality issues and performance measures for management review.

  • May liaise with external vendors.

Required Qualifications

  • Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.

  • At least 3 years' work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.

  • Demonstrate understanding of how their function supports the business.

  • Demonstrates technical and business competencies that drive results and continuous improvement.

Preferred Qualifications

  • Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11

Apply Now (https://www.jobs.abbott/us/en)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/ (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow 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.

Connect with us at abbott.com , on LinkedIn at https://www.linkedin.com/company/abbott-/ , and on Facebook at https://www.facebook.com/AbbottCareers .

The base pay for this position is $68,000.00 – $136,000.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [email protected]

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