Complaint Investigator

Are you looking for an exciting role with the Complaint Management Center (CMC) team! Join our team of regulatory compliance professionals who are at the forefront of investigating global product performance, ensuring Agilent's products are safe and effective for those being diagnosed.

Operating within the Product Quality & Incident Management organization, supporting Global Quality and Regulatory Affairs (GQRA), the Complaint Investigator will join the Complaint Management Center (CMC) team located near Austin, in Cedar Creek, Texas.

We are looking for a seasoned medical device/IVD professional who is eager to work in a dynamic and progressive environment. This role is crucial for ensuring the quality of our products and identifying early signs of potential issues. The Complaint Investigator will be hands-on, involved in the initial evaluation, investigation, processing, and closing of complaints, as well as assessing reportability to regulatory authorities, contributing to metrics, and ensuring timely complaint processing. You will collaborate closely with Agilent's Quality and Regulatory teams, Field Team, Product Support, Research & Development, and manufacturing organizations to ensure thorough investigations.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Review service records to identify product issues related to medical device/IVD quality complaints.

• Document comprehensive and accurate findings for each complaint investigation, including reportability assessment, root cause, conclusions, and corrective actions in compliance with regulatory requirements.

• Communicate and escalate investigation results and facilitate the decision-making process for failure investigations.

• Collaborate with cross-functional teams, including R&D, Quality, Manufacturing, Support and Service, Logistics, Regulatory Affairs, and Medical Affairs, to address product safety and quality issues.

• Support quality system investigations, including nonconformances, corrective actions, and preventive actions.

• Update and maintain complaint investigation procedures to ensure alignment with current standards and best practices.

• Conduct and facilitate product and process training sessions to enhance team competency.

• Participate in the analysis, tracking, and trending of complaints data for Global Quality and Regulatory Affairs meetings on a weekly and monthly basis and drive quality improvements.

• Provide support for global and local audits and inspections, ensuring compliance with regulatory standards and organizational requirements.

Remote Work:

• This position primarily allows for remote work. Candidates must be based in the US and may be required to attend meetings and events at the Agilent office in Cedar Creek, Texas, as needed.

• Bachelor's degree in Biological Sciences or related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry).

• Minimum 3+ years of related experience in medical device post-market product surveillance and complaint handling.

• Strong analytical and problem-solving skills, with excellent written and verbal communication abilities.

• Proficient in data analysis and workflow troubleshooting, including instrumentation, arrays, and biological materials.

• Proven ability to manage and prioritize workload, meet deadlines, and work effectively in a dynamic environment.

• Exceptional organizational skills and attention to detail.

• Experience with SAP is preferred. Proficiency in Microsoft Office Products (Word, Excel, PowerPoint) or equivalent software applications is preferred.

• Flexibility and a positive outlook toward handling new processes, technology, and general change.

• Familiarity with ISO 13485, 21 CFR 820, 21 CFR 803, and QSR quality management system requirements and IVD products.

Additional Details