Remote Complaints Engineer II: Product Quality & MDR

Terumo Cardiovascular Group; Elkton (MD); Remote; USD 47,000 - 66,000; Full time

Benefits offered by this job

Annual bonus

Paid vacation

Health benefits

401(k) plan

Job summary

Terumo Medical Corporation in Elkton, MD is seeking a Complaints Engineer II to lead investigations of customer complaints for medical devices, ensuring compliance with FDA, ISO, QSR, EU MDR and other regulations. The role involves cross-functional teamwork, testing, and preparation of reports and customer letters.

The candidate will support continuous improvement, perform data analysis, and interact with clinical, regulatory, and management teams to resolve issues and ensure patient safety.

Qualifications

• Strong knowledge of medical device regulations (FDA, MDR) and complaint handling.
• Experience in investigating customer complaints and CAPA processes.
• Excellent written and verbal English communication; technical writing skills.

Responsibilities

• Lead complaint investigations with cross-functional teams and write investigation reports.
• Conduct product analyses on returned samples and perform retention/testing.
• Prepare regulatory reports (MDR, Vigilance) and customer communications.

Skills

Analytical thinking

Regulatory knowledge

Technical writing

English communication

Education

Engineering or life sciences bachelor

Tools

MS Office

Minitab

Job description

Terumo Medical Corporation in Elkton, MD is seeking a Complaints Engineer II to lead investigations of customer complaints for medical devices, ensuring compliance with FDA, ISO, QSR, EU MDR and other regulations. The role involves cross-functional teamwork, testing, and preparation of reports and customer letters.

The candidate will support continuous improvement, perform data analysis, and interact with clinical, regulatory, and management teams to resolve issues and ensure patient safety.