Manager, Field Action Process

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

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.
Learn about the Danaher Business System which makes everything possible.
The Manager, Field Action Process is responsible for managing Cepheid’s global Field Action process and ensuring consistent, compliant execution of field actions, recalls, corrections, removals, field safety corrective actions, customer notifications, and related post-market actions. Directly manages professional associates responsible for field action execution, including workload prioritization, coaching, performance feedback, development, and resource planning. This role provides day-to-day leadership for process execution, standard work adherence, record quality, regulatory alignment, and inspection readiness. The Manager will drive disciplined daily management, timely escalation, continuous improvement, and cross-functional coordination to ensure field action activities are executed in accordance with applicable FDA, ISO 13485, EU IVDR/MDR, and other global regulatory expectations.
This position reports to the Director, Adverse Events and Field Actions and is part of the Post Market Quality Organization located in Sunnyvale, CA and will be an on-site role.

In This Role, You Will Have The Opportunity To

• Manage daily execution of the global Field Action process, including initiation, assessment, Field Action Board inputs, regulatory strategy, customer communication, distributor coordination, effectiveness checks, reconciliation, and closure readiness.
• Ensure field action standard work is consistently followed across records, owners, regions, and functional partners, with clear expectations for documentation quality, traceability, objective evidence, and timely completion of required process steps.
• Provide regulatory and quality oversight for field action decisions and documentation to support alignment with FDA recall expectations, 21 CFR Part 7, 21 CFR Part 806, ISO 13485, EU IVDR/MDR, Health Canada, and other applicable global requirements.
• Lead daily management routines, action tracking, aging reviews, issue escalation, and metric reviews to maintain process control and prevent delays.
• Review and approve field action documentation, including Field Action Reports, reportability assessments, regulatory submissions, Field Safety Notices, distribution lists, effectiveness check plans, response reconciliations, and closure packages.
• Identify recurring process gaps, documentation inconsistencies, audit findings, training needs, and execution risks, and translate them into corrective actions, standard work improvements, governance enhancements, and measurable process improvements.
• Support regulatory inspections, notified body audits, internal audits, and management reviews by maintaining audit-ready field action records, defensible rationale, objective evidence, and clear process performance metrics.

The Essential Requirements Of The Job Include

• Bachelor’s degree in Science, Engineering, Quality, Regulatory Affairs, Life Sciences, or related discipline with 9+ years of relevant experience; OR Master’s degree with 7+ years of relevant experience.
• Experience managing people, processes, or cross-functional programs within the medical device, in vitro diagnostic, biotechnology, pharmaceutical, or similarly regulated industry.
• Demonstrated knowledge of field actions, recalls, corrections and removals, complaint handling, adverse event reporting, regulatory reporting, customer communications, and post-market quality system processes.
• Working knowledge of FDA recall and correction/removal expectations, including 21 CFR Part 7 and 21 CFR Part 806, as well as ISO 13485, risk management principles, and global field action reporting expectations.
• Experience implementing or sustaining standard work, daily management, process metrics, dashboards, escalation routines, audit readiness reviews, and continuous improvement activities in a regulated quality system.
• Ability to identify documentation gaps, reconcile objective evidence across multiple records, clarify process ownership, and ensure records support traceable, inspection-ready conclusions.
• Strong communication, coaching, prioritization, and stakeholder-management skills, with the ability to lead through ambiguity, drive timely decisions, and escalation compliance risks appropriately.

It would be a plus if you also possess previous experience in:

• Direct management of global field actions, recalls, corrections and removals, or field safety corrective actions for in vitro diagnostic or medical device products.
• Experience leading teams through regulatory inspections, notified body audits, internal audits, CAPA execution, or remediation of field action process findings.
• Experience using Danaher Business System tools, daily management, visual management, standard work, kaizen, problem solving, and process-improvement methods to improve quality system performance.
• Regulatory Affairs Certification (RAC), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Lean certification, or similar professional certification.

The annual salary range for this role is $129,500 – 178,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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