Full-Time

Quality Assurance Engineering Specialist I

Posted on 5/8/2024

Penumbra Inc

Penumbra Inc

1,001-5,000 employees

Develops healthcare technology for vascular conditions

Hardware

Mid

Alameda, CA, USA

Requirements
  • Bachelor’s degree in a scientific or engineering discipline
  • 1+ years of quality systems experience in regulated device or pharmaceutical environment
  • Excellent oral, written, and interpersonal communication skills
  • Problem-solving and documentation 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
  • 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) and domestic and global quality system regulations, standards, and procedures
  • Understand relevant security, privacy, and compliance principles and adhere to applicable regulations, standards, and procedures
  • Ensure other department members follow QMS, regulations, standards, and procedures
  • Perform other work-related duties as assigned

Penumbra, Inc. is renowned for its specialized focus on advanced healthcare technologies aimed at improving treatments for neuro and peripheral vascular conditions. Through its comprehensive product range, including breakthrough solutions like the REAL Immersive System and ACE Reperfusion Catheters, the company maintains a crucial role in enhancing patient care. Employees at Penumbra thrive in a culture dedicated to technical excellence and leadership in medical innovation, making it a highly regarded employer in the healthcare industry.

Company Stage

IPO

Total Funding

$3.4M

Headquarters

Alameda, California

Founded

2004

Growth & Insights
Headcount

6 month growth

5%

1 year growth

11%

2 year growth

21%