What are the responsibilities and job description for the Senior Quality Assurance Scientist position at The Fountain Group?
Senior QA Scientist | Chaska, MN
- Pay: $40-46.53/hr.
- 6-month assignment with possibility for extension or conversion based on performance and budget.
- Review and ensure accuracy and compliance of Instructions for Use (IFUs) and Change Orders, particularly for label revisions.
- Provide Quality Assurance support for reagent manufacturing processes in alignment with cGMP, FDA QSR, and ISO standards.
- Enforce design change procedures, corporate policies, and regulatory requirements to prevent deviations and non-conformances.
- Collaborate with cross-functional teams to assess, contain, and disposition non-conforming products.
- Partner with development, technical operations, and manufacturing teams to uphold quality standards, reduce rework, and improve product satisfaction.
- Drive daily quality management actions that support organizational initiatives and compliance objectives.
- Evaluate quality system performance, identify improvement opportunities, and lead continuous improvement activities to enhance efficiency and compliance.
- Bachelor’s degree with 5 years, Master’s degree with 3 years, or PhD with relevant industry experience is required
- Quality assurance background within a regulated environment is required, QA within medical device highly preferred
- EDMS experience is highly preferred
- IFU (instructions for use) experience is preferred
Salary : $40 - $47
