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Complaints Engineer II
Terumo Medical CorporationPosted 10/21/2026contractRemote • Maryland • United StatesMid-LevelSenior💰 $34 - $48 per hourWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in complaint investigation and resolution within the medical device industry, ensuring compliance with FDA, ISO, and other regulatory standards. Proficient in data analysis, technical writing, and effective communication to support post-market surveillance and quality assurance activities.
Highest-signal resume keywords
Complaint InvestigationRegulatory ComplianceData AnalysisTechnical WritingQuality Assurance
About the role
Key responsibilities & impact- Analyze, evaluate, and investigate complaints from external customers
- Drive complaint investigation activities with cross-functional team members
- Prepare complaint investigation reports and customer letters
- Assign and conduct testing of retention and returned samples
- Perform engineering evaluations, data analysis, additional testing, simulation testing, and root-cause investigations on returned devices
- Ensure compliance with FDA, ISO, QSR, EU MDR, and other regulatory requirements
- Support accurate and timely Medical Device Reports and Vigilance Reports
- Compile Post Market Safety Update Reports for assigned product lines
- Collect follow-up information from customers, medical professionals, field staff, Sales, Field Service, and Terumo affiliates
- Assess adverse-event reportability decisions
- Act as Post Market Surveillance subject matter expert for assigned product lines
- Convene complaint-trending meetings, present failure analyses, document minutes, and follow up on action items
- Ensure timely and complete complaint and failure investigations and closure
- Investigate and document field clinical events and potentially visit customers for critical issues
- Maintain complaint-handling site procedures
- Gather, analyze, trend, and report complaint metrics and systemic issues
- Present critical information at business reviews
- Provide engineering expertise for installation, validation, and qualification of complaint-investigation test equipment
- Assist with area layouts, flow analysis, equipment procurement, and training
- Plan work schedules and expenditures, attend meetings, and prepare monthly reports
- Provide support, assistance, and training to team members
Requirements
What you’ll need- Minimum of a 4-year degree in engineering, life sciences, or equivalent technical degree and a minimum of three years’ experience in a medical device quality assurance or clinical environment, or equivalent combination of relevant education and experience
- Minimum of 4 years’ experience in a quality, customer complaint investigation/resolution, or clinical experience in medical device industry (disposable devices)
- Thorough knowledge of standards and regulations for medical devices
- Strong analytical and problem-solving skills
- Excellent written and oral English communication skills, including technical writing skills
- MS Office (Word, PowerPoint, Excel) experience
- Ability to interact with individuals and groups at all levels
- Good presentation/training skills
- Knowledge of record keeping, computer software, laboratory procedures for sample evaluation, and complaint-handling and MDR/vigilance reporting procedures
- Ability to manage multiple tasks accurately with high attention to detail
- Ability to identify priorities and function independently
- Minitab proficiency preferred
- Strongly preferred clinical experience or in-depth knowledge of interventional products and medical procedures
- ASQ Certification qualification desirable (e.g., CQE, CQIA)
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
- Short-term disability
- Critical illness and accident insurance
- Parental leave
- Personal leave
- Tuition reimbursement
- Travel assistance
- Employee assistance program
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data AnalysisComplaint InvestigationRoot-Cause InvestigationEngineering EvaluationMinitab ProficiencyMedical Device ReportingSample EvaluationComplaint Metrics ReportingPost Market SurveillanceQuality Standards Knowledge
Soft Skills
Analytical SkillsProblem-Solving SkillsCommunication SkillsPresentation SkillsAttention to Detail
Tools & Technologies
MS OfficeComplaint-Handling SoftwareLaboratory Procedures
Certifications & Qualifications
ASQ CertificationCQECQIA
Industry Keywords
Medical DeviceQuality AssuranceClinical EnvironmentInterventional ProductsRegulatory RequirementsVigilance ReportingPost Market Safety Update