Sr. Manager, Quality Science & Technology (CDx)

Location: Carpinteria, California, United States

Salary: $136,618–$213,465 per year, plus eligibility for bonus, stock, and benefits

Company

hirify.global develops analytical, diagnostic, and laboratory technologies, including companion diagnostic solutions.

What you will do

• Lead the CDx Design Assurance team and provide quality oversight across multiple development projects.
• Direct design controls, risk management, development planning, verification and validation, clinical performance evaluation, and commercial launch quality activities.
• Approve quality documents, procedures, and records, and maintain accurate Quality Management System processes.
• Coordinate quality and regulatory activities, resources, budgets, milestones, project changes, and cross-functional initiatives.
• Support product investigations, field actions, regulatory-agency interactions, and internal and external quality audits.
• Coach employees, establish objectives, provide training, and promote continuous quality and process improvement.

Requirements

• Bachelor’s or Master’s degree, or equivalent directly relevant experience.
• At least 2 years of experience leading people, projects, or programs in Quality.
• Experience with ISO 13485, FDA CFR 21 820, IVDR, and IVD or medical-device regulations in the EU and United States.
• Strong analytical and problem-solving skills focused on compliant solutions.
• Experience in IVD, medical devices, pharmaceuticals, or another regulated industry is highly desired.
• Ability to work at the Carpinteria, California location.

Culture & Benefits

• Full-time daytime schedule with occasional travel.
• Bonus, stock, and benefits eligibility.
• Opportunities to collaborate across hirify.global divisions and with pharmaceutical partners.
• Focus on customer-centered quality, regulatory compliance, and continuous improvement.