Temp Complaint Specialist II

Terumo•Davie, FL

3d•Onsite

About The Position

The Complaint Handling Specialist II is responsible for the analysis 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. At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy. The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida. Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. Join us and help shape wherever we go next! Advancing healthcare with heart www.terumoaortic.com

Requirements

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.
Must be able to manage multiple tasks and perform with accuracy and high attention to detail.
Ability to identify priorities and function independently required.
Knowledge of national and international regulations applicable to medical devices.
Minimum of an Associate’s degree required.
Minimum 3 years’ experience in quality complaint handling within the medical device industry required.
Relevant experience in medical device industry required.

Nice To Haves

Bachelor’s degree in science, healthcare (Nursing, Paramedicine, Cardiac Cath Lab Technician, etc.), or equivalent technical degree is preferred.

Responsibilities

Receives customer complaints daily related to product quality and patient safety.
Generates complaints and customer feedback in the complaints software system.
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 due diligence 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.
Makes Adverse Event Reportability decisions in accordance with US and International regulations in collaboration with Complaints Quality Engineering and Adverse Event Reporting Specialist.
Works closely with Complaints Quality Engineering, Adverse Event Reporting Specialists, and support departments to process complaint and customer feedback records.
May have to assist with assembly of laboratory packs and send to customers in a timely manner as applicable.
Performs other job-related duties as assigned.