Field Action Specialist

Agilent Technologies•Avon Lake, OH

12d•Remote

About The Position

The Product Quality Incident Management (PQIM) Field Action Specialist’s responsibilities include managing Field Action Activities for medical and non-medical products. This role involves developing and leading Field Action strategies and Field Safety Execution meetings, as well as managing recalls, field notifications, advisory notices, and correction processes for both medical and non-medical products. Key responsibilities include preparing customer notification and acknowledgement letters, coordinating field notices, and submitting required communications to Health Authorities and notified bodies. Additionally, you will manage status updates, draft follow-up letters, and monitor regulatory termination requests to ensure timely and compliant closure of all actions. The position includes monitoring of the escalated product quality issues, executing the Field Actions, and verification of their effectiveness until closure by: Collaborate with product investigation and CAPA teams to gather event information and document investigations for presentation in decision-making meetings. Generate consignee lists and coordinate notifications and customer contacts with Field Service teams. Review and verify investigation summaries and quality documentation to ensure compliance and readiness for regulatory inspections. Develop field action strategies, draft safety notices and customer letters, and manage stakeholder reviews for accuracy and alignment. Report field actions to global Health Authorities and notified bodies, and work closely with in-country teams to ensure timely execution. Maintain and enhance QMS processes and procedures related to Field Actions, driving continuous improvement. Track customer follow-ups and acknowledgements, ensuring documentation is clear, accurate, and inspection-ready. Communicate updates across the broader Agilent organization regarding Field Action activities. Monitor and influence progress on Field Action status updates by hosting meetings and following up with in-country contacts, documenting all efforts. Engage with global Health Authorities to inform them of actions, provide status updates, and request closure of Field Actions. Demonstrate excellent writing and communication skills, representing Agilent professionally to internal teams and global regulatory bodies.

Requirements

Bachelor’s or master’s degree in engineering or a Scientific/Technical discipline
Minimum 8 years of relevant professional experience in the Medical Device (MD), In Vitro Diagnostics (IVD), Pharmaceutical, or related Life Science industry.
Minimum 8 years of experience managing remedial actions, including Field Actions, Field Safety Notices (FSN), or Field Safety Corrective Actions.
Exceptional professional writing skills in English, with the ability to communicate clearly and effectively with global regulatory authorities and internal stakeholders.
Strong knowledge and prior experience with FDA, EU MDR, and Health Canada field action regulations and execution processes.

Responsibilities

Evaluate escalation data related to potential Field Actions and determine appropriate next steps.
Support business investigation teams by reviewing presentation materials, ensuring investigations are thorough, and follow-up actions are addressed promptly.
Collect, extract, and analyze data related to product corrections, including CAPAs, NCRs, and SCARs associated with Field Actions.
Notify relevant bodies (e.g., TUV, UL, or others) of Field Action decisions in compliance with regulatory requirements.
Provide metrics and reporting for Field Actions to support Executive Management Reviews, business Management Reviews (MRs), and other product review meetings.
Stay current on evolving regulations and guidelines within the IVD space and recommend changes to maintain compliance.
Analyze and evaluate systems and processes regularly to identify opportunities for improvement and enhance service to internal stakeholders.
Participate in internal and external quality audits, including planning, execution, and follow-up activities.
Perform ad-hoc tasks related to the Field Action process as needed.
Support Field Action investigations, ensuring timely and accurate data collection and documentation.
Lead and participate in cross-functional projects addressing Field Action-related issues and driving resolution.