Quality Assurance Engineering Specialist I

About the role

The Quality Assurance Engineering Specialist I supports quality engineering activities to ensure compliance with domestic and international regulations. They analyze data to draw conclusions and follow standards and procedures.

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.
• Afford assistance in various other Quality Specialist tasks as needed.

Qualifications

• Minimum education and experience: 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.
• Additional qualifications: Excellent oral, written, and interpersonal communication skills, problem-solving and documentation skills.

Location and Pay

Alameda, CA
Starting Base Salary is $30.00 to $40.00/hour

What We Offer

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes 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, and paid sick time in compliance with applicable law(s).