QA Complaint Associate

4 weeks ago

Indianapolis Indiana, United States Eurofins USA PSS Insourcing Solutions Full time
Job Description

Monitor, triage and assign complaints timely and appropriately.

Understand the devices to support investigations as defined in associated complaint procedures.

Perform and/or lead detailed complaint investigations.

Perform examinations on returned complaint samples as applicable.

Ensure timely completion of complaint investigations.

Supports ad hoc complaint requests when necessary.

Utilize Failure Modes and Effects Analysis (FMEA), as applicable.

Utilize non-routine software tools or business systems to complete complaint investigations.

Ensure compliance with Medical Device Reporting (MDR) and other regulatory reporting requirements.

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