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Senior Quality Engineer

Katalyst Healthcares & Life Sciences
  • Sherrill, NY
  • Instant Apply
2 days ago

Job Description

Roles & Responsibilities:
  • Lead manufacturing, plant, product, supplier, and reliability quality activities across high-volume manufacturing and assembly operations.
  • Develop, implement, and maintain Quality Management Systems (QMS) in accordance with applicable ISO standards and company requirements.
  • Drive continuous quality improvement initiatives across manufacturing processes to reduce defects, scrap, rework, and customer complaints.
  • Perform structured Root Cause Analysis using 8D, 5 Why, Fishbone Diagram, and other problem-solving methodologies.
  • Lead the development and implementation of Corrective and Preventive Actions (CAPA) and verify their effectiveness.
  • Support and manage APQP, PPAP, DFMEA, PFMEA, Control Plans, and Product Development Quality activities.
  • Analyze customer complaints, warranty claims, field failures, production non-conformities, and internal quality issues to identify root causes and implement corrective actions.
  • Collaborate with Design Engineering, Manufacturing, Operations, Supply Chain, Production, and Supplier teams to resolve quality and reliability issues.
  • Lead continuous improvement programs using Lean Manufacturing, Six Sigma, Kaizen, Poka-Yoke, and other quality improvement methodologies.
  • Develop and maintain SPC, MSA, FMEA, Control Plans, Process Audits, Risk Assessments, and other quality documentation.
  • Monitor manufacturing processes and establish appropriate quality controls to ensure products meet customer and engineering specifications.
  • Conduct supplier quality audits, supplier assessments, and supplier development activities.
  • Work with suppliers to identify quality issues, establish corrective actions, and improve supplier performance.
  • Review and interpret engineering drawings, specifications, GD&T requirements, CAD data, and product documentation.
  • Support manufacturing processes including machining, fabrication, assembly, casting, welding, electrical assembly, and process manufacturing.
  • Lead quality investigations involving process deviations, non-conforming materials, production defects, and product failures.
  • Establish and monitor key quality metrics and prepare quality reports, dashboards, and management presentations.
  • Lead cross-functional quality teams and coordinate activities among quality engineers, inspectors, technicians, manufacturing engineers, suppliers, and operations personnel.
Preferred Experience:
  • Minimum 12+ years of experience in Manufacturing Quality, Plant Quality, Supplier Quality, Product Quality, or Reliability Engineering.
  • Proven experience driving quality improvements in high-volume manufacturing and assembly environments.
  • Strong understanding of Quality Management Systems (QMS), ISO standards, and manufacturing quality processes.
  • Hands-on experience in Root Cause Analysis using methodologies such as 8D, 5 Why, Fishbone Diagram, or similar structured problem-solving tools.
  • Experience implementing and sustaining Corrective and Preventive Actions (CAPA).
  • Strong knowledge of APQP, PPAP, DFMEA, PFMEA, Control Plans, and Product Development Quality processes.
  • Experience analyzing customer complaints, warranty claims, field failures, and production non-conformities.
  • Ability to work effectively with Design, Manufacturing, Supply Chain, Operations, and Supplier teams to resolve quality issues.
  • Experience leading continuous improvement initiatives using Lean Manufacturing, Six Sigma, Kaizen, Poka-Yoke, or equivalent methodologies.
  • Strong understanding of manufacturing processes such as machining, fabrication, assembly, casting, welding, electrical assembly, or process manufacturing.
  • Experience with supplier quality management, supplier audits, and supplier development activities.

Numbers & Facts

LocationSherrill, NY

Skills

  • 8Dunmatched
  • Advanced Product Quality Planning (APQP)unmatched
  • Analysis Skillsunmatched
  • Auditingunmatched
  • CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing)unmatched
  • Castingunmatched
  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Design Failure Mode and Effects Analysis (DFMEA)unmatched
  • Documentationunmatched
  • Engineering Drawingunmatched
  • Failure Mode and Effects Analysis (FMEA)unmatched
  • Geometric Dimensioning and Tolerancingunmatched
  • ISO (International Organization for Standardization)unmatched
  • Identify Issuesunmatched
  • Leadershipunmatched
  • Lean Manufacturingunmatched
  • Lean Six Sigmaunmatched
  • Machiningunmatched
  • Manufacturingunmatched
  • Manufacturing Assemblyunmatched
  • Manufacturing Engineeringunmatched
  • Manufacturing Operationsunmatched
  • Manufacturing/Industrial Processesunmatched
  • Performance Managementunmatched
  • Problem Solving Skillsunmatched
  • Process Failure Mode and Effects Analysis (PFMEA)unmatched
  • Process Improvementunmatched
  • Process Manufacturingunmatched
  • Product Developmentunmatched
  • Product Documentationunmatched
  • Product Planningunmatched
  • Production Part Approval Process (PPAP)unmatched
  • Quality Assuranceunmatched
  • Quality Engineeringunmatched
  • Quality Managementunmatched
  • Quality Metricsunmatched
  • Quality Monitoringunmatched
  • Reporting Dashboardsunmatched
  • Reporting Skillsunmatched
  • Risk Analysisunmatched
  • Root Cause Analysisunmatched
  • Structured Analysisunmatched
  • Supply Chain Operationsunmatched
  • Systems Maintenanceunmatched
  • Team Lead/Managerunmatched
  • Technical/Engineering Designunmatched
  • Vendor/Supplier Evaluationunmatched
  • Vendor/Supplier Quality Managementunmatched
  • Vendor/Supplier Selectionunmatched
  • Weldingunmatched
  • Wire Harnessunmatched

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