AbbottIrving, Texas, United States · On-site
$68k–$136k/yr
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…
Skills: Quality Assurance, Complaint handling, Regulatory compliance, GMP, CFR
AbbottDublin, Leinster, Ireland · On-site
Abbott Undergraduate Internship Programme Unlock Your Potential at Abbott Looking for an opportunity to apply your academic knowledge, gain hands-on experience, and make a real impact? Abbott's Undergraduate Internship P…
Skills: Data analytics, Cybersecurity, Digital transformation, Communication, Teamwork
AbbottLucknow, Uttar Pradesh, India · Remote OK
JOB DESCRIPTION:Primary Job Function • Achieving assigned territory/ geography wise sales target • Carrying out effective field work without direct day-to-day supervision • Report field work in daily basis on assigned on…
Skills: Sales, Territory management, Communication, Analytical skills, Relationship building
AbbottMinnetonka, Minnesota, United States · On-site
$78k–$156k/yr
Senior Manufacturing Engineer 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 dev…
Skills: Operations Readiness, Design Transfer, Process Validation, Process FMEA, Lean Manufacturing
AbbottMumbai, Maharashtra, India · Remote OK
JOB DESCRIPTION:Main Responsibilities Collect, compile, verify, and analyze financial, competitive, sales, marketing, and other information about potential business partners, new markets, products and services, or other …
Skills: Financial analysis, Market research, Business development, Strategic planning, Sales reporting
AbbottWiesbaden, Hesse, Germany · On-site
JOB DESCRIPTION: Über Abbott Abbott ist ein weltweit führendes Unternehmen im Gesundheitswesen, das bahnbrechende wissenschaftliche Erkenntnisse nutzt und Lösungen zur Verbesserung der Gesundheit der Menschen entwickelt.…
Skills: Field Service, Molecular Diagnostics, Biomedical Engineering, Electrical Engineering, Mechatronics
AbbottLos Angeles, California, United States · On-site
$90k–$180k/yr
Job Description MAIN PURPOSE OF ROLE Supports production and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing…
Skills: PLC Programming, Industrial Robotics, Machine Vision Systems, Controls Engineering, Equipment Validation
AbbottMadison, Wisconsin, United States · On-site
$25/hr–$50/hr
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 diagnost…
Skills: Laboratory analysis, Specimen processing, Quality control, Equipment maintenance, Troubleshooting
AbbottLake Forest, Illinois, United States · On-site
$78k–$156k/yr
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 diagnost…
Skills: Software Quality Assurance, Risk Management, Validation Packages, FDA QSR Compliance, ISO Guidelines
AbbottNew Brighton, Minnesota, United States · On-site
$78k–$156k/yr
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 diagnost…
Skills: Supplier quality engineering, FDA regulations, ISO 13485, ISO 14971, GMP
AbbottMadison, Wisconsin, United States · On-site
$25/hr–$50/hr
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 diagnost…
Skills: Laboratory analysis, Specimen processing, Quality control, Equipment maintenance, Troubleshooting
AbbottWinston-Salem, North Carolina, United States · Remote OK
$61k–$123k/yr
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 diagnost…
Skills: Clinical Support, Sales Support, Interventional Cardiology, Cardiac Surgery, Patient Education
AbbottSturgis, Michigan, United States · On-site
$19/hr–$38/hr
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 diagnost…
Skills: Machine operation, Manufacturing, Equipment maintenance, Troubleshooting, Sanitization
AbbottMadison, Wisconsin, United States · On-site
$25/hr–$50/hr
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 diagnost…
Skills: Laboratory analysis, Specimen processing, Quality control, Equipment maintenance, Troubleshooting
AbbottLake Forest, Illinois, United States · Remote OK
$78k–$156k/yr
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 diagnost…
Skills: Operational Excellence, Process Improvement, Change Management, Lean Six Sigma, Project Management
AbbottHouston, Texas, United States · On-site
$78k–$156k/yr
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 diagnost…
Skills: Structural Heart, Interventional Cardiology, Clinical Support, Sales Support, Procedure Coverage
AbbottMadison, Wisconsin, United States · On-site
$51k–$101k/yr
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 diagnost…
Skills: Manufacturing support, Equipment maintenance, Troubleshooting, Process improvement, Engineering design
AbbottPrinceton, New Jersey, United States · On-site
$99k–$199k/yr
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 diagnost…
Skills: Regulatory labeling, IVD product portfolio, Regulatory affairs, Labeling strategy, UDI implementation
AbbottUnited States · Remote OK
$169k–$312k/yr
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 diagnost…
Skills: Sales management, Strategic planning, Market analysis, Team leadership, Coaching
AbbottBirmingham, England, United Kingdom · On-site
We have a fantastic opportunity, initially on a temporary basis (12 months) to join our phenomenal Electrophysiology (EP) business, where we’re advancing the treatment of heart disease through breakthrough medical techno…
Skills: Clinical Consultation, Cardiac Anatomy, Cardiac Physiology, Technical Support, Product Presentation
Abbott
Irving, Texas, United States • On-site
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The Specialist Quality Assurance analyzes customer complaints to determine regulatory reportability and coordinates investigations with internal and external stakeholders. They ensure adherence to GMP and other governmental regulations while documenting findings and corrective actions.
Candidates must have a Bachelor's degree in Life Science, Engineering, or a related discipline. A minimum of 3 years of experience in Quality or a related field is required, with preference given to those with experience in regulated industries.
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 Dallas, TX 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 Specialist Quality Assurance will analyze customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
What You’ll Work On
Conduct investigations related to quality events and customer complaints in compliance with applicable regulations and internal procedures.
Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
Apply clinical knowledge, as related to product application, to evaluate identified complaints.
Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
Composed written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
Ensure investigation and records are completed accurately, thoroughly, and in accordance with regulatory and quality system requirements.
Support audits and inspections by providing documentation and demonstrating compliance with quality system requirements.
Utilize root cause analysis tools and problem-solving methodologies to drive continuous improvement and maintain compliance.
Contributes to defining and timely achievement of overall project goals. Scope typically limited to one specific QA function.
Provides compliant solutions to a variety of problems of moderate scope and complexity.
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.
Design Control / Documentation & Change Control - Identifies areas for process improvement.
Provides supporting information for change including reasons and justifications.
Quality Engineering - Coordinates quality decisions between different quality and engineering groups.
Participate in the development or modification of validation packages, design plans, and risk management deliverables (e.g. FMEAs). Team members helping and interfacing with suppliers to deliver products meeting our quality requirements.
Receives general direction and exercises considerable discretion to own work detail. Recommend possible solutions. Provides compliant solutions to a variety of complex problems.
Required Qualifications
Bachelors – Apprenticeship or Bachelor’s degree in Life Science, Engineering, or closely related discipline, or an equivalent combination of education and work experience.
Minimum 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred Qualifications
Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement.
Experience working within a regulated industry such as medical device, diagnostics, pharmaceutical, biotechnology, or other regulated industries) is a plus.
Experience leading or supporting CAPA activities, investigations, root cause analysis, and quality system compliance activities.
Knowledge of quality system requirements, risk management principles, and regulatory expectations related to investigations and/or CAPA processes.
Excellent written and verbal communications skills.
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 – $136,000.00. In specific locations, the pay range may vary from the range posted.
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, nutritional and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on X @AbbottNews. 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. Terms of Use: https://www.abbott.com/social-media-terms-of-use.html Privacy Policy: https://abbo.tt/privacy
Offices: 100 Abbott Park Road, Abbott Park, Illinois 60064-3500, US
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, nutritional and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on X @AbbottNews. 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. Terms of Use: https://www.abbott.com/social-media-terms-of-use.html Privacy Policy: https://abbo.tt/privacy
Offices: 100 Abbott Park Road, Abbott Park, Illinois 60064-3500, US