Entry-Level Complaints Quality Engineer: MDR & Investigations

Terumo Medical Corporation; Elkton (MD); On-site; USD 60,000 - 75,000; Full time

Job summary

Terumo Medical Corporation is seeking an entry-level Complaints Quality Engineer I in Elkton, MD. You will analyze customer complaints, evaluate investigations for MDR and regulatory compliance, and support the reporting process under FDA/ISO/QSR guidelines.

You will interact with medical professionals, field staff and cross-functional teams to drive timely and thorough investigations. Responsibilities include collecting follow-up information, preparing reports, and performing testing on

Qualifications

• Prefer a 4-year degree in life sciences or engineering.
• Zero to three years of medical device QA or clinical experience.
• Excellent written and oral English skills.
• Ability to manage multiple tasks with accuracy and attention to detail.

Responsibilities

• Promotes continuous improvement per Terumo Quality Policy and regulatory requirements.
• Ensure compliance with FDA, ISO, QSR and MDR reporting.
• Collaborate with QA team and cross-functional stakeholders to support investigations.
• Prepare complaint investigation reports and customer letters.
• Perform testing on returned devices and conduct data analysis and root-cause investigations.
• Maintain complaint handling site procedures and related metrics.

Skills

Analytical thinking

Problem solving

Effective communication

Team collaboration

Education

Life sciences or engineering degree

Tools

MS Office

Job description

Terumo Medical Corporation is seeking an entry-level Complaints Quality Engineer I in Elkton, MD. You will analyze customer complaints, evaluate investigations for MDR and regulatory compliance, and support the reporting process under FDA/ISO/QSR guidelines.

You will interact with medical professionals, field staff and cross-functional teams to drive timely and thorough investigations. Responsibilities include collecting follow-up information, preparing reports, and performing testing on