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Senior Specialist, Quality Engineer L3Harris Technologies
Mason, OHToday
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Skills
- Analysis Skillsunmatched
- CMM Inspectionunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Cross-Functionalunmatched
- Data Analysisunmatched
- Design Failure Mode and Effects Analysis (DFMEA)unmatched
- Documentationunmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- Geometric Dimensioning and Tolerancingunmatched
- Healthcareunmatched
- Healthcare Qualityunmatched
- ISO (International Organization for Standardization)unmatched
- Identify Issuesunmatched
- Implantsunmatched
- Lean Six Sigmaunmatched
- Maintain Complianceunmatched
- Manufacturing Engineeringunmatched
- Manufacturing Equipmentunmatched
- Manufacturing/Industrial Processesunmatched
- Mechanical Engineeringunmatched
- Medical Equipmentunmatched
- Medical Productsunmatched
- Medical Protocolsunmatched
- Minitabunmatched
- Operational Supportunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Process Analysisunmatched
- Process Capabilityunmatched
- Process Failure Mode and Effects Analysis (PFMEA)unmatched
- Process Validationunmatched
- Product/Service Launchunmatched
- Production Systemsunmatched
- Quality Assurance Methodologyunmatched
- Quality Engineeringunmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Root Cause Analysisunmatched
- Six Sigmaunmatched
- Six Sigma Black Beltunmatched
- Six Sigma Certificationunmatched
- Six Sigma Green Beltunmatched
- Statisticsunmatched
- Surgical Suppliesunmatched
- Systems Analysisunmatched
- Team Playerunmatched
- Technical Drawingunmatched
- Technical Trainingunmatched
- United States Department of Energy (DOE)unmatched
- Validation Testingunmatched
- Vendor/Supplier Evaluationunmatched
- Vendor/Supplier Selectionunmatched
Description
Summary:
Quality Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives.Roles & Responsibilities:
- Experience in a GMP and/or ISO regulated medical industry is required.
- Ability to analyze and present data that facilitates & drives decision making is required.
- The ability to perform "hands on " troubleshooting and problem solving is required Experience working in an FDA regulated environment is preferred.
- Experience working in operations supporting a production environment is preferred Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferred
- Technical understanding of manufacturing equipment and processes is preferred Process Validation expertise is preferred.
- Ability to read and interpret CMM and dimensional inspection reports.
- Experience with dimensional data analysis utilizing software (Excel or Minitab)
- Experience in Medical Standards and Quality process preferred.
- New product launch experience from through full validation and commercial launch
- Experience with PFMEA/DFMEA's, Gage R&R's, TMV's, Risk Assessments and Control Plan
- Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
- Performance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.
- Strong communication skills and ability to work well within a multidisciplinary team.
- Proficient with GD&T and interpreting technical drawings.
- Green or Black Belt Six Sigma certification preferred.
Requirements:
- Process Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R)
- Statistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab)
- Medical Device Quality Systems (GMP, ISO 13485, FDA Compliance)
- Bachelor's in mechanical engineering or equivalent and have min. 5 years' experience working as a Quality, Validation and or Manufacturing Engineering role in a Medical Product industry required.
- Required medical domain experience. Surgical Product and Implants experience preferred.
Numbers & Facts
| Location | Cincinnati, OH |
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