Complaints Quality Engineer I

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

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

 

Job Summary

This entry level engineering position is responsible for analyses, evaluation and product investigation 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.  Drives all complaint investigation activities with cross functional team members.  The Complaints Quality Engineer I provides support and assistance in the evaluation of Complaints for Medical Device Report (MDR) and all Adverse Event reports. Responsible for reporting of complaints, evaluation of returned products, processing of trending analysis, and composing customer letters in accordance with Terumo Medical Corporation procedures, and regulatory requirements. The Complaints Quality Engineer I will interact with medical professionals, marketing, customers, customer service, clinical, regulatory, NPD, and management to support in the complaint investigations. 

Job Details/Responsibilities

1.    Promotes a work environment of continuous improvement that supports Terumo Quality Policy, Quality System, and the appropriate regulations.  
2.    Accountable for compliance with applicable US and International regulations and directives; including, but not limited to Food & Drug Administration (FDA), Canadian and European Union Medical Device Directives (MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV).  Assists with generation of Medical Device Reports (MDRs) and Vigilance Reports as required.
3.    Work in a team environment with members of the QA group on achieving team metrics requirements. 
4.    Collecting follow up information related to complaints from customers; typically, through the Sales and/or Field Service groups. 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.
5.    Collaborate in assessing Adverse Event Reportability decisions in accordance with US and International regulations.
6.    Responsible for driving all complaint investigation activities with cross functional team members and prepares complaint investigation reports, assigns test on retention and returned samples and write customer letters.  
7.    Perform retention, decontamination and testing of returned devices. Perform data analysis, additional testing, simulation testing, and root cause investigations and resolution in support of a thorough complaint investigation related to product quality and patient safety.  
8.    Ensure timely, accurate and complete complaints and failure investigations of returned products. Ensure timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries.
9.    Assist with communicating business related issues or opportunities to next management level immediately.
10.    May be required to perform customer visits to assist i