Global Field Action Process Manager – Quality & Compliance

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

Job summary

Cepheid, a Danaher company located in Sunnyvale, CA, seeks a Manager for the Field Action process to lead global action execution, ensure regulatory alignment, and drive continuous improvement within post-market quality systems.

The role emphasizes cross-functional leadership, documentation quality, inspection readiness, and collaboration with regulatory bodies to maintain FDA and international standards compliance.

Qualifications

• Bachelor’s degree or higher in a relevant scientific/regulatory field.
• Master’s degree with additional relevant experience is a plus.
• Regulatory certifications (RAC/CQE/CQA) are desirable.

Responsibilities

• Manage daily execution of the global Field Action process, including initiation, assessment, and closure readiness.
• Provide regulatory and quality oversight for field action decisions and documentation.
• Lead daily management routines, aging reviews, and metric reviews to maintain process control.

Skills

Strong communication

Coaching

Prioritization

Stakeholder management

Education

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

Master’s degree

Regulatory Affairs Certification (RAC) or CQE/CQA

Job description

Cepheid, a Danaher company located in Sunnyvale, CA, seeks a Manager for the Field Action process to lead global action execution, ensure regulatory alignment, and drive continuous improvement within post-market quality systems.

The role emphasizes cross-functional leadership, documentation quality, inspection readiness, and collaboration with regulatory bodies to maintain FDA and international standards compliance.