Quality Professional

1003 Abbott Laboratories; United States; On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

FreeU education program

Global employer recognition

Job summary

Abbott Park, IL, USA, is seeking a Quality/Process role in Transfusion Medicine. You will participate in design/change control, risk management, and verification/validation activities to ensure safe, effective products. Responsibilities include documentation reviews and maintaining quality system compliance across projects.

Required: a Bachelor’s in Life Science or Engineering and 3+ years in quality. Experience with FDA/QSR/ISO 21 CFR 11 is preferred.

Qualifications

• Bachelor’s degree in Life Science, Engineering, or closely related discipline.
• At least 3 years of work experience in Quality or related field; advanced degree may reduce requirement.
• Understanding of how function supports the business.

Responsibilities

• Design/change control activities across development and transfer.
• Risk management file development and updates (FMEA, etc.).
• Design verification/validation, protocols, data summaries, and records review.

Skills

Quality engineering

Risk management

Documentation

Education

Bachelor’s degree in Life Science, Engineering, or related

Tools

FDA regulations

QSR

21 CFR 11

Job description

JOB DESCRIPTION:

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.

• 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 bachelor’s 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 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.

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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.

Job Details

• JOB FAMILY: Operations Quality
• DIVISION: TM Transfusion Medicine
• LOCATION: United States > Abbott Park : AP20
• 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)

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

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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

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