Remote Complaints Engineer II - Medical Devices (Temp)

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) with matching

Tuition reimbursement

Travel assistance

Employee assistance program

Job summary

Terumo Medical Corporation in Elkton, MD is seeking a Complaints Engineer II to lead investigations of external customer complaints, ensure regulatory compliance, and drive post-market surveillance activities. You will interact with medical professionals, sales, service, and regulatory teams to resolve issues and generate timely MDR/Vigilance reporting.

The role requires a 4-year engineering or life sciences degree and at least three years in medical device quality/complaint handling, with

Qualifications

• Thorough knowledge of standards and regulations for medical devices.
• Strong analytical and problem-solving skills.
• Excellent written and oral English communication skills; technical writing is required.
• Ability to interact with multiple groups at all levels and manage multiple tasks.
• Knowledge of MDR/vigilance reporting and quality systems is preferred.
• Minitab proficiency is preferred.

Responsibilities

• Promotes a continuous improvement environment aligned with quality policies and regulations.
• Ensures compliance with FDA, EU MDR, and other regulatory requirements; manages MDR/vigilance reporting.
• Collaborates with cross-functional teams to drive complaint investigations and data analysis.
• Performs testing and analysis of returned devices; drafts customer letters and reports.
• Convenes trending meetings and documents action items with clear closure.
• Provides training and guidance on complaints processes and post-market surveillance.

Skills

Analytical skills

Problem solving

English writing

Attention to detail

Multitasking

Education

Bachelor's degree in engineering, life sciences, or equivalent

Tools

Minitab

MS Office

Job description

Terumo Medical Corporation in Elkton, MD is seeking a Complaints Engineer II to lead investigations of external customer complaints, ensure regulatory compliance, and drive post-market surveillance activities. You will interact with medical professionals, sales, service, and regulatory teams to resolve issues and generate timely MDR/Vigilance reporting.

The role requires a 4-year engineering or life sciences degree and at least three years in medical device quality/complaint handling, with