Penumbra, Inc. is hiring a
Quality Assurance Engineering Specialist I in United States

Summary

The Quality Assurance Engineering Specialist I supports quality engineering activities to ensure compliance with regulations. Duties include assembling sterile loads, completing documents, verifying accuracy of data, communicating with facilities and labs, adhering to the QMS and regulations, and performing other tasks as needed. A Bachelor’s degree in a scientific or engineering discipline and 1+ years of quality systems experience are required, along with excellent communication skills.

Requirements

• Bachelor’s degree in a scientific or engineering discipline with 1+ years of quality systems experience in regulated device or pharmaceutical environment or an equivalent combination of education and experience
• Excellent oral, written, and interpersonal communication skills

Responsibilities

• Assemble sterile loads and complete associated documents for sterilization and product release
• Complete sample submission forms for shipping and testing
• Verify and document accuracy of sterilization process, biological test results, and completion of Device History Records (DHRs)
• Communicate with sterilization facility and test laboratories as needed
• Perform ongoing data entry, review, and analysis of data to support statistical process control
• Maintain and control quality record files and archived records
• Interface with other internal departments, customers, and suppliers on quality-related issues
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures