Overview In this role you will lead the CDx Design Quality team to ensure design controls, risk management, verification and validation, and regulatory readiness across the CDx portfolio. You will act as the primary quality liaison between Global Quality and CDx, guiding improvements and aligning stakeholders to meet quality and regulatory expectations. The position drives QMS maintenance, process improvements, and collaboration with internal teams and external partners to deliver compliant, patient-safe products. You will shape quality culture, anticipate risks, and enable successful development programs and partnerships at scale. A key attraction is the opportunity to influence quality across CDx,药
Compensation / Benefits Responsibilities- Oversee design controls, risk management, and quality processes across product development
- Provide quality leadership for CDx development projects and timely resolution of quality issues
- Approve quality documents, procedures, and records
- Maintain and improve QMS processes within the area of responsibility
- Support product investigations, field actions, and regulatory interactions
- Lead QMS improvement initiatives to enhance compliance and efficiency
- Provide coaching, training, and consultation on quality systems and methodologies
- Manage design assurance team and oversee development planning, V&V, and risk management
- Ensure alignment with regulations, policies, and business objectives
- Collaborate across Agilent divisions to integrate CDx input into global processes
- Participate in audits and host auditors when needed
- Drive activities to establish standardized best practices with other CDx teams
- Develop and nurture a culture of collaboration and customer-focused quality
Key requirements- Bachelor's or Master's Degree or equivalent plus relevant experience
- 2+ years' experience leading people, projects, or programs in Quality
- Experience with ISO13485, FDA CFR , IVDR and IVD/Medical Devices regulations
- Strong analytical and problem-solving skills focused on compliant solutions
- Experience in IVD/Medical Devices or regulated pharmaceutical environments is highly desired
- leadership
- collaboration
- communication
- Quality Management System (QMS)
- design controls
- risk management
