General Summary 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.
Specific Duties and 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
*Indicates an essential function of the role
Position Qualifications Minimum education and experience:
- Bachelor's degree in engineering, microbiology, or scientific related field with 1+ years of experience, or equivalent combination of education and experience
Additional 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
Working Conditions - General office, laboratory, and cleanroom environments
- Willingness and ability to work on site.
- May have business travel from 0%- 5%
- 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.
Location: Alameda, CA Annual Base Salary Range: $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.
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).
