Entry-Level Complaints Quality Engineer

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

Job summary

Terumo Medical Corporation, Elkton, MD, seeks an entry level Complaints Quality Engineer I to analyze and investigate customer complaints on medical devices in compliance with FDA, ISO, QSR and related regulations. You will drive complaint investigations with cross-functional teams and support MDR/Adverse Event reporting.

You will interact with medical professionals, marketing, field service and regulatory teams to gather information, write customer letters and ensure timely closure of

Qualifications

• Strong analytical and problem-solving abilities.
• Excellent written and oral English communication; technical writing proficiency.
• Experience with MS Office Suite (Word, PowerPoint, Excel).

Responsibilities

• Promote continuous improvement in line with Terumo Quality Policy and regulations.
• Ensure compliance with FDA, ISO, QSR and other regulatory directives; assist with MDRs and Vigilance reports.
• Collaborate with QA and cross-functional teams to achieve metrics.
• Collect follow-up information from customers via Sales/Field Service to support investigations.
• Assist in assessing Adverse Event reportability decisions per regulations.
• Drive all complaint investigations with cross-functional teams and prepare reports.
• Conduct retention, decontamination and testing of returned devices; perform data analysis and root cause investigations.
• Ensure timely, accurate closure of complaints to comply with regulatory requirements.
• Communicate business issues or opportunities to management promptly.
• May perform customer visits to assist in investigations of critical issues.
• Maintain complaint handling site procedures.
• Assist with compiling complaints metrics and data analyses.
• Prepare responses to customers and field per process.

Skills

Anatomy & Physiology

Medical devices

Analytical skills

Technical writing

MS Office

Education

4-year degree in life sciences or engineering

Tools

MS Office

Job description

Terumo Medical Corporation, Elkton, MD, seeks an entry level Complaints Quality Engineer I to analyze and investigate customer complaints on medical devices in compliance with FDA, ISO, QSR and related regulations. You will drive complaint investigations with cross-functional teams and support MDR/Adverse Event reporting.

You will interact with medical professionals, marketing, field service and regulatory teams to gather information, write customer letters and ensure timely closure of