Complaint Investigator

Job Title

Job Description

Your role:

• Leads the implementation of good faith efforts (GFE), diligently reviews, and analyzes supplementary data as required to fortify the investigation process and demonstrates a commitment to thoroughness and accuracy. • Leads the end-to-end investigation of complaints, including condensing pertinent information, analyzing findings, and presenting a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented. • Reviews customer response letters (CRL) or internal responses upon concluding the investigation, utilizes effective communication and problem-solving skills, and escalates complex matters to appropriate channels for further assistance and resolution. • Utilizes analytical skills to resolve medium complexity requests by exercising judgment within established procedures, analyzing complaint data, gathering additional information to assess potential product enhancements, defects, and safety issues. • Handles moderate to high complexity investigations into post-market complaints and adverse events, ensures thorough and timely resolution by analyzing complaint data and documentation to identify trends, root causes, and potential product issues.
• You're the right fit if:
• Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or a related field; or vocational education with at least 4 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, QMS and regulatory requirements, technical documentation, data analysis, root cause analysis, and CAPA methodologies. Medical-device vigilance reporting experience is a plus.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
• How we work together
• We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities.
• Leads the implementation of good faith efforts (GFE), diligently reviews, and analyzes supplementary data as required to fortify the investigation process and demonstrates a commitment to thoroughness and accuracy.
• Leads the end-to-end investigation of complaints, including condensing pertinent information, analyzing findings, and presenting a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented.
• Reviews customer response letters (CRL) or internal responses upon concluding the investigation, utilizes effective communication and problem-solving skills, and escalates complex matters to appropriate channels for further assistance and resolution.
• Utilizes analytical skills to resolve medium complexity requests by exercising judgment within established procedures, analyzing complaint data, gathering additional information to assess potential product enhancements, defects, and safety issues.
• Handles moderate to high complexity investigations into post-market complaints and adverse events, ensures thorough and timely resolution by analyzing complaint data and documentation to identify trends, root causes, and potential product issues.

About Philips

Qualifications

• Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or a related field; or vocational education with at least 4 years of relevant experience.