Senior CDx Design Quality Lead

Agilent; Carpinteria (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Agilent in Carpinteria, CA seeks a Design Quality Manager to lead the CDx Design Assurance team, overseeing design controls, risk management, verification, validation, and development quality activities to ensure compliance with quality systems and regulatory requirements.

The role serves as the primary quality representative for the CDx business, coordinating with Global Quality, escalating issues, and partnering with internal teams and external collaborators to drive continuous improvement and

Qualifications

• Bachelor's or Master's degree in a relevant field with quality/regulatory experience.
• Proven leadership of cross-functional design quality teams.
• Experience with design controls, risk management, and V&V in medical devices or CDx.

Responsibilities

• Lead the CDx Design Assurance team to oversee design controls and quality processes across development programs.
• Provide quality leadership and oversight for CDx projects, including timely resolution of quality issues.
• Approve quality documents, procedures, and records as required.
• Maintain and improve QMS processes within the area of responsibility.
• Collaborate with regulatory bodies and external partners to ensure compliance.

Skills

Leadership

Quality management

Design controls

Risk management

QMS

Regulatory liaison

Education

Bachelor's or Master's Degree in a related field

Tools

QMS software

Job description

Agilent in Carpinteria, CA seeks a Design Quality Manager to lead the CDx Design Assurance team, overseeing design controls, risk management, verification, validation, and development quality activities to ensure compliance with quality systems and regulatory requirements.

The role serves as the primary quality representative for the CDx business, coordinating with Global Quality, escalating issues, and partnering with internal teams and external collaborators to drive continuous improvement and