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 103,000 colleagues serve people in more than 160 countries.
Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes; which adds value to the business.
Key Responsibilities :
- 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 - Applies basic Risk Management principles to work. Participates in the development or modification of Risk management files.
- 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.
- Validation - Participates in the development or modification of validation records. Review and approves validation packages with guidance from senior team members.
- Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions.
- Complaint Evaluation – May support by investigating 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.
- Ensures compliant documentation; carrying out tasks related to area of responsibility with management oversight.
- Bachelors’ degree in Life Science, Engineering, or closely related discipline is required.
- At least 3 years work experience in Quality or related field. 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.