Quality Assurance Engineer I

Role Overview

• Ensure compliance to the Quality System procedures, corporate policies, and global regulations (21CFR820, ISO13485, ISO14971)
• Non-conformance and planned deviations SOP / DMR updates through change orders
• Equipment qualifications / validations
• Stop ships / containment
• Identify continuous improvement opportunities and utilize DBS to drive improvements cross-functionally with development, technical operations, and manufacturing to ensure quality
• Reduce defects/ non-conformances
• Increase productivity
• Reduce operator cycle time

Requirements

• Bachelor’s degree in engineering (i.e. Mechanical or Electrical)
• 0-2+ years' relevant experience
• CQE preferred
• Experience in the medical device industry preferred

Benefits

• Health care program
• Paid time off
• Medical/dental/vision insurance
• 401(k)