Quality Assurance Engineering Specialist I
Penumbra•Alameda, CA
•$30 - $40•Onsite
About The Position
The Quality Assurance Engineering Specialist I will support quality engineering activities to ensure the compliance of these systems with domestic and international regulations. They will follow standards and procedures in analyzing data from which conclusions can be readily obtained.
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
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.
- 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.
Benefits
- medical
- dental
- vision
- life
- AD&D
- short and long-term disability insurance
- 401(k) with employer match
- paid parental leave
- eleven paid company holidays per year
- a minimum of fifteen days of accrued vacation per year, which increases with tenure
- paid sick time in compliance with applicable law(s)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
