Product Stewardship Specialist I (Medical Devices)

Location: Alameda, CA, United States; on-site

Annual base salary: $72,000–$94,000

Company

hirify.global develops medical devices and operates within a regulated healthcare environment.

What you will do

• Support assigned quality system functions and provide compliance status for global sustainability regulations.
• Assess product materials and formulations against EU MDR, REACH, CA Prop 65, RoHS, and related requirements.
• Generate and maintain product documentation and quality-system records.
• Use a chemical substance management system to perform product stewardship activities.
• Evaluate internal controls, analyze data, and support quality-system improvements.
• Support FDA inspections, notified body audits, supplier-data reviews, and cross-functional quality activities.

Requirements

• Bachelor's degree in engineering, microbiology, or a related scientific field with 1+ years of experience, or an equivalent combination of education and experience.
• Basic knowledge of FDA QSR, ISO standards, product stewardship regulations, and the MDR.
• Strong oral, written, and interpersonal communication skills.
• High accuracy, attention to detail, organization, and ability to manage multiple projects.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Willingness and ability to work on site in Alameda, California.

Nice to have

• Experience in medical devices, pharmaceuticals, biotechnology, or another regulated industry.

Culture & Benefits

• Work takes place in office, laboratory, and cleanroom environments.
• Competitive compensation package with benefits and equity program when applicable.
• Business travel may be required for 0%–5% of working time.
• Physical activities include moving between buildings and floors and lifting or moving items weighing up to 25 pounds.
• The role requires extended computer and office-equipment use and regular communication with employees at all levels.