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Staff Quality Specialist

Katalyst CRO

Role overview

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, Business Administration, or a related discipline required
  • Minimum 7+ years of experience in Quality Systems, Quality Assurance, Regulatory Affairs, Compliance, Process Excellence, or a related function within the medical device industry
  • 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

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

Key facts

Hard skills

Regulatory Compliance Process Improvement Change Control Risk Management Verification And Validation Auditing ISO 13485 Standard

Other skills

  • Quality Assurance
  • Communication
  • Collaboration
  • Problem Solving

About the company

Katalyst CRO logo

Katalyst CRO

Contract Research Organizations (CRO)

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Company details

IndustryContract Research Organizations (CRO)
Company size51 - 200

Links

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Job 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.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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