Full-Time
Quality Assurance Engineering Specialist I
Posted on 4/17/2024
Develops healthcare technologies for vascular conditions
Mid
Roseville, CA, USA
- 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
- 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)
- 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
- 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
Penumbra, Inc. excels in pioneering healthcare technologies specifically designed for neuro and peripheral vascular conditions. This involves a focus on stroke revascularization and embolization, with leading products like the REAL Immersive System and ACE Reperfusion Catheters that underline their commitment to top-tier, patient-focused innovations. Their dedication to leveraging cutting-edge technology in medical solutions makes it an outstanding workplace for professionals eager to impact critical care positively and advance in the fast-evolving healthcare sector.
Company Stage
IPO
Total Funding
$3.4M
Headquarters
Alameda, California
Founded
2004