Penumbra
Product Stewardship Specialist I
Alameda, CA · Junior
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About the role
- Follow standards and procedures in analyzing data from which conclusions can be readily obtained.
- Make guided decisions appropriate to the system(s) being supported.
- Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.
Responsibilities
- The Product Stewardship Specialist I develops, implements, and provides primary support for functions associated with quality system elements (e.g., EU MDR, REACH, CA Prop 65, etc.) to ensure the compliance of these systems with domestic and international regulations.
- Support or take the primary responsibility for the assigned quality system(s) *
- 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 *
- Perform other work-related duties as assigned
Requirements
- 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.
Nice to have
- 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
Compensation
- $72,000 - $94,000
- We offer a competitive compensation package plus a benefits and equity program, when applicable.
- Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
Benefits
- We offer a competitive compensation package plus a benefits and equity program, when applicable.
- Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need.
Equal opportunity
- For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
This listing is sourced directly from Penumbra's careers page and normalized into a canonical job model.