Senior Complaint Investigator – Medical Devices

Philips; Bothell (WA); Presencial; USD 71.000 - 98.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO

401k matching

Health Savings Account

Stock purchase plan

Education reimbursement

Descripción de la vacante

Philips in Bothell, WA is seeking a Complaint Investigator to lead end-to-end investigations of highly complex complaints, condense information, analyze findings, and present a clear overview with proposed resolutions.

The role requires a Bachelor's degree in a related field or equivalent experience, knowledge of post-market surveillance and CAPA, and ability to work onsite with regular collaboration across teams. You will help ensure regulatory compliance and contribute to product safety.

Formación

• 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.

Responsabilidades

• Lead the end-to-end investigation of complaints, condense pertinent information, analyze findings, and present a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented.
• Review customer response letters (CRL) or internal responses upon concluding the investigation, utilize effective communication and problem-solving skills, and escalate complex matters to appropriate channels for further assistance and resolution.
• Utilize 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.
• Handle moderate to high complexity investigations into post-market complaints and adverse events, ensure thorough and timely resolution by analyzing complaint data and documentation to identify trends, root causes, and potential product issues.

Conocimientos

Data analysis

Root cause analysis

CAPA

Regulatory knowledge

Educación

Bachelor's degree or equivalent in Medical Sciences/Healthcare Management/Industrial Engineering/Supply Chain Management or related field

Descripción del empleo

Philips in Bothell, WA is seeking a Complaint Investigator to lead end-to-end investigations of highly complex complaints, condense information, analyze findings, and present a clear overview with proposed resolutions.

The role requires a Bachelor's degree in a related field or equivalent experience, knowledge of post-market surveillance and CAPA, and ability to work onsite with regular collaboration across teams. You will help ensure regulatory compliance and contribute to product safety.