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Staff Quality Specialist

Katalyst Healthcares & Life Sciences

  • Parsippany, NJ
  • 6 days ago
  • Remote
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    Skills

    • Analysis Skillsunmatched
    • Auditingunmatched
    • Best Practicesunmatched
    • Biologyunmatched
    • Business Administrationunmatched
    • Change Controlunmatched
    • Change Managementunmatched
    • Continuous Improvementunmatched
    • Continuous Integrationunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Customer Acquisitionunmatched
    • Customer Support/Serviceunmatched
    • Document Controlunmatched
    • Document Managementunmatched
    • Documentationunmatched
    • Documentation Reviewunmatched
    • Documentation Standardsunmatched
    • FDA (Food and Drug Administration)unmatched
    • Gap Analysisunmatched
    • ISO (International Organization for Standardization)unmatched
    • Insurance Regulationsunmatched
    • Maintain Complianceunmatched
    • Medical Equipmentunmatched
    • Microsoft Officeunmatched
    • Needs Assessmentunmatched
    • Procedure Developmentunmatched
    • Process Analysisunmatched
    • Process Improvementunmatched
    • Product Lifecycle Managementunmatched
    • Quality Assuranceunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Quality System Requirements (QSR)unmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Requirements Managementunmatched
    • Risk Managementunmatched
    • Support Documentationunmatched
    • System Architectureunmatched
    • Systems Administration/Managementunmatched
    • Technical/Engineering Designunmatched
    • Traceabilityunmatched
    • Vendor/Supplier Evaluationunmatched

    Description

    Job Summary:
    • The Staff Quality Specialist will evaluate and harmonize existing Quality Management System (QMS) procedures, work instructions, forms, templates, and related documentation across multiple quality subprocesses.
    • The role is responsible for identifying opportunities for process simplification, standardization, and global harmonization while supporting the development and implementation of future-state quality system processes.
    • This position partners with cross-functional stakeholders to redesign processes, improve documentation consistency, and ensure compliance with applicable regulatory and quality standards.
    Roles & Responsibilities:
    • Review, assess, and harmonize quality system procedures, work instructions, forms, templates, and related controlled documentation across multiple QMS subprocesses.
    • Evaluate current-state processes to identify redundancies, inconsistencies, gaps, and opportunities for standardization, simplification, and global harmonization.
    • Develop redlined revisions and consolidated documentation supporting scalable global processes while maintaining regulatory compliance.
    • Partner with process owners and subject matter experts to define future-state workflows, roles, responsibilities, decision points, and required controls.
    • Analyze interactions and dependencies across QMS subprocesses including Change Control, Document Control, Training, CAPA, Nonconformance, Complaint Handling, Supplier Quality, Design Controls, Risk Management, Validation, Audits, and Management Review.
    • Support the development of globally aligned procedures, process maps, templates, forms, training materials, and governance frameworks.
    • Facilitate cross-functional working sessions to gather requirements, resolve process conflicts, and build consensus on standardized approaches.
    • Establish traceability between current-state and future-state process requirements to support implementation, compliance, and organizational change management.
    • Ensure all proposed revisions are clear, practical, audit-ready, and aligned with business objectives, regulatory requirements, and industry best practices.
    • Document recommendations, decisions, risks, open items, and implementation considerations to support management review and stakeholder approval.
    • Participate in quality system transformation, remediation, integration, and continuous improvement initiatives.
    • Support implementation readiness activities including impact assessments, training needs analysis, communication planning, and deployment support.
    • Provide expertise on quality system documentation architecture, procedural hierarchy, and document standardization.
    • Identify opportunities to reduce procedural complexity, improve user adoption, and increase efficiency while maintaining quality and regulatory compliance.
    Education & Experience:
    • Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, Business Administration, or a related discipline required; advanced degree (MBA, MS, or equivalent) preferred.
    • Minimum 7+ years of experience in Quality Systems, Quality Assurance, Regulatory Affairs, Compliance, Process Excellence, or a related function within the medical device industry.
    • Experience developing, reviewing, revising, and implementing controlled quality system documentation, including procedures, work instructions, forms, templates, and process documentation.
    • Proven experience supporting or leading QMS harmonization, remediation, transformation, standardization, or continuous improvement initiatives across multiple functions, sites, or geographic regions.
    • Experience conducting procedural assessments, gap analyses, process mapping, and documentation reviews.
    • Strong understanding of QMS subprocesses including Change Control, Document Control, CAPA, Nonconformance Management, Training, Audits, Supplier Quality, Design Controls, Risk Management, Validation, Complaints, and Management Review.
    • Working knowledge of ISO 13485, FDA QSR/QMSR, EU MDR, and other applicable global quality standards.
    • Experience facilitating cross-functional workshops and driving stakeholder alignment.
    • Experience with eQMS, PLM systems, document management systems, and Microsoft Office applications.
    • ASQ certifications (CQE, CQA, CMQ/OE) or equivalent certifications are desirable.

    Numbers & Facts

    LocationParsippany, NJ (
    Remote    )

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