Specialist Quality Assurance at Abbott in Illinois

Specialist Quality Assurance Location: United States - Illinois - Abbott Park 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 115,000 colleagues serve people in more than 160 countries. 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, IL location in the Transfusion Medicine 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 Professional Quality Assurance Conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes, which add value to the business. What You’ll Work On 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. Interact constructively with employees, managers, and cross-functional peers. May lead a project with a limited scope, but usually a contributor on broader projects. Provides guidance to other Professionals and Technicians. Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensure 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. Risk Management - Applies basic Risk Management principles to work. Participate in the development or modification of Risk management files. Complaint Evaluation - Investigates complex complaints with management oversight. Ensures compliant documentation related to area of responsibility. 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. Participates 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. Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight. Decisions may have short- and long-term impact. Proactively identifies systemic quality issues and drives cross-functional continuous improvement initiatives (e.g., CAPA effectiveness, trending, systemic root cause elimination). Takes full ownership of assigned quality systems, ensuring deliverables are met on time with minimal oversight. Effectively challenges decisions when quality or compliance risk is identified. Acts as a quality subject matter expert (SME) within assigned area. Participates in internal, external, and regulatory audits; supports audit readiness and response activities. Required Qualifications Bachelors degree, 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. Demonstrates management of competing priorities in a dynamic environment while maintaining compliance and quality standards. Apply Now 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. JOB FAMILY: Operations Quality DIVISION: TM Transfusion Medicine LOCATION: United States > Abbott Park : AP08B 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), Work requiring repeated bending, stooping, squatting or kneeling 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