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 compliance with domestic and international regulations. Follows standards and procedures in analyzing data to draw clear conclusions and makes guided decisions appropriate to the system(s) being supported.

Responsibilities

• Support or take primary responsibility for 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 systems.
• Generate and maintain product documentation for relevant sustainability regulations and quality systems.
• Utilize chemical substance management system to perform tasks.
• Support ongoing evaluation of internal controls, analysis, and maintenance of documentation to improve systems.
• Verify quality records associated with the quality system(s) to assure accuracy and conformance.
• Support management during FDA inspections and/or other notified body audits.
• Interface with other internal departments on quality-related issues and 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 applicable regulations, standards, and procedures.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Requirements

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

Working Conditions

• General office, laboratory, and cleanroom environments.
• Willingness and ability to work on site.
• Business travel from 0% - 5%.
• Requires some lifting and moving of up to 25 pounds.
• Able to move between buildings and floors.
• Able to remain stationary and use a computer or other standard office equipment for extensive periods each day.
• Able to read, prepare emails, and produce documents and spreadsheets.
• Able to move within the office and access file cabinets or supplies as needed.
• Able to communicate and exchange accurate information with employees at all levels on a daily basis.

Location: Alameda, CA

Pay

Annual Base Salary Range: $72,000 - $94,000

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, increasing with tenure.
• Paid sick time in compliance with applicable law(s).
• Equity program, when applicable.

A collaborative teamwork environment where learning is constant, and performance is rewarded. Opportunity to be part of a team revolutionizing the treatment of some of the world's most devastating diseases.