Complaints Specialist I

Terumo•Elkton, MD

6d•$53,000 - $73,920

About The Position

The Complaint Handling Specialist I is responsible for analyses and control of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR) and other regulatory guidelines. Facilitates all complaint investigation activities with cross functional team members and prepares complaint investigation reports. Responsible for assisting with the inspection and testing of retention and return samples and summarizing the findings to support complaint investigations.

Requirements

Requires a minimum 2 years experience in a quality or customer service/complaint resolution in medical device industry (disposable devices).
Thorough knowledge of standards and regulations for medical devices.
Strong analytical and problem solving skills.
Excellent written and oral English communication skills required.
MS Office (Word, PowerPoint, Excel) experience required.
Ability to interact with individual and groups at all levels.
Good presentation/training skills required.
Mathematical knowledge including algebra/statistics; utilization of sampling plans and statistical charts.
Typically requires a logical thought process and decision making ability.
Ability to use testing equipment.
Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
Ability to identify priorities and function independently required.
Requires a high school diploma; post high school is beneficial.

Nice To Haves

An Associate’s Degree in science / healthcare or equivalent technical degree is preferred.

Responsibilities

Investigates customer complaints daily related to product quality and patient safety. Log complaints in the complaints software system and support in their investigation.
Support in the testing of returned samples and assist in the review of Device History Records.
Maintains oversight of the complaints and daily processes to ensure issues are being addressed in a timely and thorough manner and conform to complaint policy and procedures.
Performs investigative tasks to support in the determination of root cause and resolution of identified complaints. This includes interactions with appropriate stakeholders including but not limited to customers, medical professionals, field staff and Terumo affiliates to obtain information pertinent to investigations.
Assemble and send laboratory packs to customers in a timely manner.
Assisting with decontaminating and testing of returned and retention products
Works closely with Complaints Engineering, Quality Engineering, and support departments to complete complaint analysis and document investigation results.
Makes Adverse Event Reportability decisions in accordance with US and International regulations in collaboration with Quality Engineering, Complaints Engineering and Compliance functions.
Assists with generation of Medical Device Reports (MDRs) and Vigilance Reports as required.
Assists in preparing responses to customers and field as necessary per process.
Assists in providing training and guidance on reporting regulations.