Quality Assurance Engineering Specialist I

Penumbra • Alameda, CA

2d • $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. Specific Duties and 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. Indicates an essential function of the role

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
• Willingness and ability to work on site.
• 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.

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

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees