The Quality Assurance Engineering Specialist I will support compliance and quality engineering activities, manage records, and ensure adherence to quality standards.
General Summary
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
Position 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/ per hour
Working Conditions
• General office, production, and cleanroom environments.
• Willingness and ability to work on site. May have business travel from 0% - 5%
• Potential exposure to blood-borne pathogens
• Requires some lifting and moving of up to 25 pounds
• 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.
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).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
Top Skills
Quality Management System (Qms)
Statistical Process Control
Penumbra Alameda, California, USA Office
Alameda, CA, United States, 94502
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