Complaints Quality Engineer I

Terumo Medical Corporation

. Analyze, evaluate, and investigate complaints received from external customers .

Posted 11/10/2026full-timeElkton • Maryland • United StatesMid-LevelSenior💰 $60,000 - $75,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in complaint investigation and analysis within the medical device industry, ensuring compliance with regulatory requirements and quality standards. Proficient in data analysis, technical writing, and effective communication with cross-functional teams.

Highest-signal resume keywords

Complaint InvestigationMedical Device Reports (MDR)Data AnalysisTechnical WritingAnatomy & Physiology Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Complaint AnalysisRoot Cause InvestigationRegulatory ComplianceQuality AssuranceData AnalysisSimulation TestingRetention TestingAdverse Event ReportingComplaint Metrics CompilationContinuous Improvement

Soft Skills

Analytical SkillsProblem SolvingEffective CommunicationAttention to DetailTeam Collaboration

Tools & Technologies

MS Office SuiteExcelWordPowerPoint

Industry Keywords

Medical DevicesRegulated IndustryQuality SystemClinical EnvironmentCustomer Complaints

About the role

Key responsibilities & impact

Analyze, evaluate, and investigate complaints received from external customers
Drive complaint investigation activities with cross-functional team members
Support evaluation of complaints for Medical Device Reports (MDR) and adverse event reports
Report complaints and evaluate returned products
Process trending analysis and compose customer letters in accordance with company procedures and regulatory requirements
Promote continuous improvement supporting Terumo Quality Policy, Quality System, and applicable regulations
Assist with generation of MDRs and Vigilance Reports
Collect follow-up complaint information from customers, medical professionals, field staff, Sales, Field Service, and Terumo affiliates
Collaborate on adverse event reportability decisions under US and international regulations
Prepare complaint investigation reports and assign testing of retention and returned samples
Perform retention, decontamination, testing, data analysis, simulation testing, root cause investigations, and resolution for returned devices
Ensure timely, accurate, and complete complaint and failure investigations and closure
Assist with communicating business issues or opportunities to management
May perform customer visits for critical issues and customer concerns
Maintain complaint handling site procedures
Compile complaint metrics
Prepare responses to customers and field personnel
Stay current with required training
May coordinate with Clinical Affairs on clinical sample investigations

Requirements

What you’ll need

Prefer a minimum of a 4-year degree in life sciences, engineering, or equivalent technical degree from an accredited university or college
Requires zero to three years experience in a medical device quality assurance or clinical environment
Strongly prefer knowledge of Anatomy & Physiology
Knowledge of Medical Devices and/or Regulated Industry helpful
Analytical and problem solving skills
Excellent written and oral English communication skills required, including technical writing skills
MS Office Suite (Word, PowerPoint, Excel) experience required
Ability to interact effectively with individuals and teams
Must be able to manage multiple tasks performed with accuracy and a high attention to detail

Benefits

Comp & perks

Annual bonus
Paid vacation
Paid holidays
Health benefits
Dental benefits
Vision benefits
401(k) with matching contributions
Tax advantage savings accounts
Legal plan
Voluntary life and AD&D insurance
Voluntary long-term disability insurance
Short term disability insurance
Critical illness insurance
Accident insurance
Parental leave
Personal leave
Tuition reimbursement
Travel assistance
Employee assistance program