Manufacturing Quality Technician

Katalyst HealthCares & Life Sciences Inc
  • new kensington, PA
    10 days ago

    Job Description

    Provide quality and manufacturing support for production operations, supplier quality, validation, and process improvement initiatives. This role will assist with manufacturing transfers, quality system compliance, and continuous improvement efforts within a regulated production environment.

    • 2+ years of experience in Manufacturing Quality, Quality Assurance, Supplier Quality, Process Quality, or Validation.
    • Hands-on experience with CAPA, NCRs, quality documentation, inspections, and audit support.
    • Familiarity with manufacturing quality systems, process validation, and regulated production environments.
    • Strong documentation, organizational, and problem-solving skills.

    Preferred Qualifications:

    • Experience in the medical device or other regulated manufacturing industry.
    • Exposure to manufacturing transfers, process validation, supplier quality, or new product introduction (NPI) activities.
    • Experience with respiratory care, ventilator, CPAP, sleep therapy, or similar healthcare products is a plus.
    • Support daily manufacturing quality activities and ensure compliance with established quality standards.
    • Assist with process validation, verification activities, and production readiness initiatives.
    • Perform inspections, maintain quality documentation, and support process monitoring activities.
    • Participate in CAPA, Non-Conformance (NCR), deviation investigations, and corrective action tracking.
    • Collaborate with Supplier Quality, Manufacturing Engineering, and Production teams to resolve quality issues and support ongoing manufacturing operations.
    • Collect, analyze, and document quality metrics, validation results, and production data.
    • Assist with internal audits, compliance initiatives, and continuous improvement projects.
    • Support manufacturing process transfers, equipment qualifications, and product transition activities.

    Numbers & Facts

    Locationnew kensington, PA

    Skills

    • Analysis Skillsunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Documentationunmatched
    • Healthcareunmatched
    • Internal Auditunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Engineeringunmatched
    • Manufacturing Operationsunmatched
    • Manufacturing Systemsunmatched
    • Manufacturing/Industrial Processesunmatched
    • Medical Equipmentunmatched
    • Operational Supportunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Process Qualityunmatched
    • Process Validationunmatched
    • Product/Service Launchunmatched
    • Production Supportunmatched
    • Production Systemsunmatched
    • Quality Assuranceunmatched
    • Quality Engineeringunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Respiratory Medicineunmatched
    • Respiratory Therapyunmatched
    • Support Documentationunmatched
    • System Validationunmatched
    • Validation Testingunmatched
    • Ventilatorunmatched

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