Hiring: Product Stewardship Specialist I Company: Penumbra, Inc. Location: Alameda, CA Job Posted Time: 2026-09-10 13:18:07 Employment Type: On-site Target Skills & Keywords : Microsoft Excel, Microsoft PowerPoint About the job Experience: •Bachelor's degree in engineering, microbiology, or scientific related field with 1+ years of experience, or equivalent combination of education and experience Required Skills: •Support or take the primary responsibility for the assigned quality system(s) * •Provide compliance status with global sustainability regulations (e.g., EU MDR, REACH, CA Prop 65, RoHS) * •Support assessment of product materials and formulations for sustainability regulations and quality system* •Generate and maintain product documentation for relevant sustainability regulations and quality system* •Utilize chemical substance management system to perform tasks* •Support ongoing evaluation of internal controls, analysis, and maintenance of documentation as it relates to supporting system improvements * •Verify quality records associated with the quality system(s) to assure accuracy and conformance * •Lead and oversee supporting management during FDA inspections and/or other notified body audits * Qualifications: •Medical device, pharmaceutical, biotech, or other regulated industry experience desired •Strong oral, written, and interpersonal communication skills •High degree of accuracy and attention to detail •Proficiency with MS Word, Excel, and PowerPoint •Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously •Basic knowledge and understanding of FDA’s QSR, ISO standards, Product Stewardship Regulations and the MDR •General office, laboratory, and cleanroom environments •Willingness and ability to work on site. •May have b usiness travel from 0 % - 5 % •Requires some lifting and moving of up to 25 pounds Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!