Senior Quality Assurance Scientist

Job Summary

A company is looking for a Senior Quality Assurance Scientist in Chaska, MN.

Key Responsibilities

• Review and ensure accuracy and compliance of Instructions for Use (IFUs) and Change Orders
• Provide Quality Assurance support for reagent manufacturing processes in alignment with cGMP, FDA QSR, and ISO standards
• Collaborate with cross-functional teams to assess and manage non-conforming products

Required Qualifications

• 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 is highly preferred
• EDMS experience is highly preferred
• IFU (Instructions for Use) experience is preferred