Abbott Quality Assurance Specialist in Abbott Park, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Primary Job Function:
Conduct Laboratory testing activities to aid in the investigation of customer complaints, deliver consistent; high quality documents; services; products and processes; which adds value to the business.
Responsible for implementing and maintaining the effectiveness of the quality system.
- General - Contributes to defining and timely achievement of overall project goals. Provides compliant
solutions to a variety of problems of moderate scope and complexity. Interacts 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. Scope typically limited to one specific QA function.
- Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures
compliance to 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 - Apply basic Risk Management principles to work. Participates in the development or modification of Risk Management files.
Complaint Evaluation - Investigates complex complaints with management oversight. Provides compliant solutions to a variety of complex problems. 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 member helping and interfacing with suppliers to deliver product meeting our quality requirements.
Position Accountability / Scope
Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions. Ensures compliant documentation; carrying out tasks related to area of responsibility with management oversight. Decisions may have short and long-term impact.
Apprenticeship or 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.
Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement.
Experience in laboratory testing preferably on Abbott equipment such as Alinity or Architect platforms
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 firstname.lastname@example.org