Complaints Quality Engineer I

Terumo•Elkton, MD

20h•$60,000 - $75,000

About The Position

This entry-level engineering position analyzes, evaluates, and investigates complaints received from external customers. The role supports compliance with FDA, ISO, Quality System Requirements, and other applicable regulatory guidelines, and drives complaint investigations with cross-functional team members. It also supports evaluation of complaints for Medical Device Reports (MDRs) and adverse event reporting; evaluates returned products, performs trending analysis, and prepares customer communications in accordance with company procedures and regulatory requirements. The engineer works with medical professionals, marketing, customers, customer service, clinical, regulatory, new product development, and management.

Requirements

Zero to three years of experience in a medical-device quality assurance or clinical environment.
Strong analytical and problem-solving skills.
Excellent written and oral English communication skills, including technical writing.
Experience with MS Office Suite, including Word, PowerPoint, and Excel.
Ability to interact effectively with individuals and teams.
Ability to manage multiple tasks accurately and with close attention to detail.

Nice To Haves

Knowledge of anatomy and physiology is strongly preferred.
Knowledge of medical devices and/or a regulated industry is helpful.
A four-year degree in life sciences, engineering, or an equivalent technical discipline from an accredited university or college is preferred.

Responsibilities

Promote continuous improvement in support of Terumo’s Quality Policy, Quality System, and applicable regulations.
Comply with applicable US and international regulations and directives, including FDA, Canadian, and European Union medical device requirements; assist in preparing MDRs and vigilance reports as required.
Work with QA team members to achieve team metrics.
Collect complaint follow-up information from customers, sales and field service groups, medical professionals, field staff, and Terumo affiliates.
Collaborate in assessing adverse-event reportability under US and international regulations.
Drive complaint investigations with cross-functional team members; prepare investigation reports, assign testing of retention and returned samples, and write customer letters.
Perform retention, decontamination, and testing of returned devices; conduct data analysis, additional and simulation testing, and root-cause investigations and resolution related to product quality and patient safety.
Ensure complaint and failure investigations are timely, accurate, and complete, and close complaints in time to meet regulatory requirements.
Communicate business-related issues or opportunities to the next management level promptly.
Visit customers as needed to investigate critical issues and concerns.
Maintain complaint-handling site procedures.
Assist in compiling complaint metrics.
Prepare responses to customers and field personnel as needed under the applicable process.
Keep current with required training.
Coordinate with Clinical Affairs on clinical sample investigations as needed.