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Senior Supplier Quality Engineer – TPR
Terumo Medical CorporationCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Supplier Management, Quality Systems, and Continuous Improvement methodologies, including Six Sigma and Lean. Proficient in evaluating supplier performance and ensuring compliance with regulatory requirements in the medical product industry.
Highest-signal resume keywords
Supplier ManagementQuality Engineering CertificationSix Sigma CertificationBilingual (English & Spanish)Medical Product Quality Experience
About the role
Key responsibilities & impact- Support the Supplier Management process and ensure suppliers and purchased components or services meet specifications and other requirements
- Provide leadership to Quality Supply Chain teams and handle employee performance and technical issues
- Lead, organize, plan, direct, and control teams to achieve expected goals
- Schedule, evaluate, discipline, coach, select, and train staff
- Review new supplier add requests for quality-system impact and required controls
- Assess supplier suitability through questionnaires, quality agreements, and supplier site evaluations
- Work with suppliers, R&D, Supply Chain, and Quality Engineering to qualify potential suppliers
- Facilitate component/material qualifications, validations, and component acceptance activities
- Assist with DFMEAs, PFMEAs, and control plans
- Identify when gage R&R studies are needed
- Manage ongoing supplier relationships and drive continuous improvement using Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis, and Lean Manufacturing concepts
- Optimize process capability through statistical analysis and train suppliers in problem-solving
- Perform root-cause analysis and recommend corrective actions
- Drive supplier verification of component and process quality at supplier locations
- Manage Supplier Corrective Action Requests and supplier nonconformance investigations
- Trend supplier metrics and analyze KPIs and Cost of Poor-Quality data
- Establish and manage continuous improvement programs, supplier ratings, and supplier scorecards
- Manage supplier databases and audit records
- Generate monthly Supplier Performance Reports
- Stay current with FDA, international, and industry regulatory requirements
- Ensure compliance with TPR procedures and applicable regulatory agency requirements
- Perform other duties as assigned
Requirements
What you’ll need- Bachelor’s or advanced degree in related engineering field or equivalent
- At least 2 years of supervisory experience
- Minimum of 7 years of related experience in supplier approval / management
- Certification as a Quality Engineer or Quality Auditor by the American Society for Quality
- Trained in Six Sigma and Lean methodology; certified as well
- Experience working with suppliers on medical product quality issues
- Experience evaluating suppliers including on-site auditing
- Must be bilingual (English & Spanish)
- Knowledge of medical product manufacturing and development
- Solid understanding of receiving inspection processes including statistical sampling, component measurement techniques, specifications, and drawings
- Thorough working knowledge of Quality systems methods and practices, including DOE, PFMEA, Control Plans, Lean Manufacturing concepts, DMAIC, and Root Cause Analysis
- Ability to understand the technology related to TMC’s products
- Understanding of CAPA and closed loop corrective action
- Proficient in spreadsheet, database, presentation, and project management tools
- Good people skills with the ability to energize and motivate a staff
- Good interpersonal and communication skills
- Strong technical business writing and oral communication skills
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
Supplier EvaluationRoot Cause AnalysisStatistical Process ControlFMEAControl PlansReceiving Inspection ProcessesQuality Systems MethodsProcess Capability OptimizationContinuous Improvement ProgramsSupplier Performance Metrics
Soft Skills
LeadershipInterpersonal SkillsCommunication SkillsCoachingMotivational Skills
Tools & Technologies
Spreadsheet ToolsDatabase ToolsPresentation ToolsProject Management Tools
Certifications & Qualifications
Quality Engineer CertificationQuality Auditor CertificationSix Sigma Certification
Industry Keywords
Medical Product ManufacturingFDA ComplianceTPR ProceduresSupplier Corrective Action RequestsSupplier Nonconformance Investigations