Quality Assurance Engineering Specialist I

May 9

Penumbra, Inc.

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Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies$1. .$1

1001 - 5000

Description

• 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. • Assist in various other Quality Specialist tasks as needed. • Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. • Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. • Ensure other members of the department follow the QMS, regulations, standards, and procedures. • Perform other work-related duties as assigned.

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 • Problem solving and documentation skills

Benefits

• General office, production, and cleanroom environments. • Willingness and ability to work on site. May have business travel from 0% - 5% • Potential exposure to blood-borne pathogens • Requires some lifting and moving of up to 25 pounds • Must be able to move between buildings and floors. • Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. • Must be able to read, prepare emails, and produce documents and spreadsheets. • Must be able to move within the office and access file cabinets or supplies, as needed. • Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.