Product Stewardship Specialist I

Penumbra • Alameda, CA

1d • $72,000 - $94,000 • Onsite

About The Position

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. Follow standards and procedures in analyzing data from which conclusions can be readily obtained. Make guided decisions appropriate to the system(s) being supported.

Requirements

• Bachelor's degree in engineering, microbiology, or scientific related field with 1+ years of experience, or equivalent combination of education and experience
• 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

Nice To Haves

• Medical device, pharmaceutical, biotech, or other regulated industry experience desired

Responsibilities

• 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
• Responsible for supporting management during FDA inspections and/or other notified body audits
• Interface with other internal departments on quality-related issues. Review supplier related data
• Provide assistance to Quality Engineering and staff on Quality System sustainability regulations and requirements
• 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

• 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
• paid sick time in compliance with applicable law(s)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level