Quality Professional
Sign up free to see how well your resume matches this role.
What you'll do
- 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.
What they're looking for
- 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.
Nice to have
- Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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. You’ll 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 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.
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
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. 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 – $136,000.00In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
TM Transfusion Medicine
LOCATION:
United States > Abbott Park : AP20
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
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
Company
Company facts come from this company's own listings. We only show what the postings themselves carry.