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Job Description 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. Job 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. Project-Related tasks 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. Qualifications 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. Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least December 30, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $87,600.00 - $164,250.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility. Travel Required: Occasional Shift: Day Duration: No End Date Job Function: Quality/Regulatory Graduate and Student Career Site Visit our career site and learn more about Agilent Watch our video playlist to get a glimpse of life at Agilent! As a global leader in laboratory and clinical technologies, we are passionate about bringing great science to life. Our commitment to quality and innovation supports cutting-edge life science research, patient diagnostics, and ensures the safety of water, food, and pharmaceuticals. As scientists and clinicians pursue small, everyday advances and life-changing discoveries, we provide trusted answers to their most critical questions and challenges. Leveraging more than 50 years of expertise, we create advanced instruments, software, and consumables supported by teams of highly skilled and knowledgeable people. With 18,000 employees around the world, our global reach and comprehensive solutions provide the most reliable and accurate results, as well as optimal scientific, economic, and operational outcomes. We work collaboratively with our customers on their journey to make a real difference in human lives. Our culture is founded on trust, respect, and uncompromising integrity, and we pride ourselves on being a dynamic and inclusive workplace that celebrates diversity and fosters innovation. We can’t wait for you to join us as we continue our mission to improve the world around us. Information about Agilent is available at Agilent.com.