Complaint Investigations Tech-29099

Primary Function / Primary Goals / Objectives:

Perform routine testing in a laboratory setting of medical devices associated with returns due to customer complaints, while ensuring timely closure. Handle multiple tasks effectively and efficiently in a team environment with minimal supervision. Document investigation activities clearly and accurately, utilizing software applications, computers and databases and maintain files per procedures. Ensure proper transfer of the returned product to next stage of investigation according to documented priorities. Store not-confirmed returned products, in appropriate location per established procedures, for subsequent retrieval.

Major Responsibilities:

Safely perform routine testing and receiving of returned products due to customer complaints and be able to document investigation activities clearly and accurately in a timely manner. Adhere to procedures and work instructions throughout.  Be able to handle multiple tasks effectively and efficiently.  Understand the priorities of investigation as outlined in the procedures and as assigned by the laboratory supervisor.

Minimum Education Required:

1-2 years of college or high school diploma with relevant experience. 

Minimum Experience/Training Required:

Good organizational, written, oral and interpersonal skills. Experience in controlled environment preferred. Good Computer Skills. Basic mathematical skills are required.  

Accountability / Scope:

Ensure that product returned is handled appropriately, investigated safely and accurately in a timely manner consistent with established procedures as failure to comply with requirements and regulations may lead to nonconformances resulting in FDA sanctions.

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