CDx Design Quality Senior Manager (IVD/Medical Devices)

Location: US-CA-Carpinteria; occasional travel required

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.
• Oversee design controls, development planning, verification and validation, risk management, commercial launch activities, and quality documentation.
• Ensure CDx products are designed and manufactured in compliance with global regulations, company policies, product specifications, and the quality management system.
• Translate regulatory requirements into practical plans and lead quality and regulatory initiatives within budget and timeline expectations.
• Coordinate with Global Quality, hirify.global divisions, development teams, pharmaceutical partners, and Pathology Design Assurance.
• Support audits, product investigations, field actions, regulatory interactions, QMS improvements, resource planning, coaching, and team development.

Requirements

• Bachelor’s or Master’s degree, or equivalent directly relevant experience.
• At least 3 years of formal or informal leadership experience involving people, projects, or programs.
• Strong knowledge of ISO 13485, FDA CFR 21 820, IVDR, and IVD/medical-device regulations in the EU and USA.
• Basic management skills and the ability to design and execute processes.
• Excellent communication, teamwork, analytical, problem-solving, independent working, and prioritization skills.
• Experience in IVD, medical devices, or the pharmaceutical industry is highly desired.

Culture & Benefits

• Full-time daytime schedule with no stated end date.
• Eligibility for bonus, stock, and employee benefits.
• Work focused on customer-centered quality, regulatory compliance, and continuous process improvement.
• Occasional travel is part of the role.