Complaint Investigator

Philips•Bothell, WA

1d•Hybrid

About The Position

The Complaint Investigator is responsible for investigating and helping resolve highly complex complaints. The role leads comprehensive investigations, manages complaint records, analyzes data for potential product enhancements and issues, ensures regulatory compliance, and supports training for new investigators on complaint handling processes and regulatory standards. The investigator leads good faith efforts (GFE), reviews supplementary data, and conducts end-to-end investigations. This includes synthesizing relevant information, analyzing findings, and presenting concise summaries of key issues, evidence, and proposed or implemented resolutions. After investigations, the role reviews customer response letters or internal responses and escalates complex matters as needed. The position also resolves medium-complexity requests, investigates moderate- to high-complexity post-market complaints and adverse events, and analyzes documentation and data to identify trends, root causes, potential product enhancements, defects, and safety issues. The role is an Office/Remote position and requires residence in or within commuting distance of Bothell, Washington. Office-based teams work in person at least three days per week; onsite roles require full-time presence at company facilities.

Requirements

Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or a related field; alternatively, vocational education with at least four years of relevant experience.
Experience in medical devices, quality assurance or control, clinical research, complaint management, or a related area.
Knowledge of post-market surveillance, quality management systems (QMS), regulatory requirements, technical documentation, data analysis, root cause analysis, and CAPA methodologies.
Must reside in or within commuting distance of Bothell, Washington.
Must have US work authorization; candidates requiring work-authorized visa sponsorship now or in the future will not be considered.
Must be able to perform the stated minimum physical, cognitive, and environmental job requirements, with or without accommodation.

Nice To Haves

Medical-device vigilance reporting experience.

Responsibilities

Lead the implementation of good faith efforts (GFE) and review and analyze supplementary data to support investigations.
Lead end-to-end complaint investigations, synthesize pertinent information, analyze findings, and present concise summaries of issues, evidence, and resolutions.
Review customer response letters or internal responses after investigations and escalate complex matters through appropriate channels.
Resolve medium-complexity requests using judgment within established procedures; analyze complaint data and gather information about potential product enhancements, defects, and safety issues.
Conduct moderate- to high-complexity investigations into post-market complaints and adverse events, ensuring thorough and timely resolution.
Analyze complaint data and documentation to identify trends, root causes, and potential product issues.
Oversee complaint records, support regulatory compliance, and support training of new investigators in complaint handling processes and regulatory standards.