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Quality Engineer

Katalyst Healthcares & Life Sciences
  • Louisville, KY
  • Quick Apply
12 days ago

Job Description

Job Description:
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 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

LocationLouisville, KY

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

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