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Senior Quality Engineer

Katalyst Healthcares & Life Sciences

  • Sherrill, NY
  • 3 days ago

    Highlights

    Analyze customer complaints, warranty claims, field failures, production non-conformities, and internal quality issues to identify root causes and implement corrective actions. Lead cross-functional quality teams and coordinate activities among quality engineers, inspectors, technicians, manufacturing engineers, suppliers, and operations personnel.

    Numbers & Facts

    LocationSherrill, NY

    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.

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