Senior Quality Assurance Scientist

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