Global Field Action Process Leader

Cepheid; Sunnyvale (CA); On-site; USD 130,000 - 178,000; Full time

Benefits offered by this job

Bonus eligible

Comprehensive benefits (medical/dental

Vision, 401(k)

Job summary

Cepheid, part of the Danaher family, is seeking a Manager for Field Action Process to oversee the global field action program from Sunnyvale, CA. You will lead multidisciplinary teams, ensure regulatory alignment, and drive continuous improvement in post-market quality activities.

The role focuses on maintaining inspection readiness and defensible, auditable records across FDA/ISO requirements while coordinating with stakeholders and managing performance metrics.

Qualifications

• Experience in regulated medical device or IVD industries is required.
• Knowledge of FDA recall/correction/removal, 21 CFR Part 7, Part 806, and ISO 13485.
• Ability to implement standard work and daily management in quality systems.

Responsibilities

• Lead daily execution of the global Field Action process and related actions.
• Ensure documentation quality, traceability and timely completion of steps.
• Provide regulatory oversight for field action decisions and records.
• Drive metrics reviews, escalation, and continuous improvement.
• Review Field Action Reports, submissions, and closure packages.
• Identify gaps and translate into corrective actions and governance.
• Support audits, inspections, and regulatory reviews with audit-ready records.

Skills

People management

Cross-functional leadership

Regulatory knowledge

Quality systems

Regulatory reporting

Education

Bachelor’s degree in Science, Engineering, Quality, Regulatory Affairs, Life Sciences, or related discipline

Master’s degree + 7+ years of relevant experience

Tools

Danaher Business System tools

Job description

Cepheid, part of the Danaher family, is seeking a Manager for Field Action Process to oversee the global field action program from Sunnyvale, CA. You will lead multidisciplinary teams, ensure regulatory alignment, and drive continuous improvement in post-market quality activities.

The role focuses on maintaining inspection readiness and defensible, auditable records across FDA/ISO requirements while coordinating with stakeholders and managing performance metrics.