Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which adds value to the business.
- General Area: 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 to moderate Risk Management principles to work.
- Problem Solving: 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.
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 Engineer: 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.
Education and Years Experience:
- Apprenticeship or relevant third level qualification in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
- At least 6 months – 1 year 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.