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.
- 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.
- nalyze 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.
- 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.
- SQ certifications (CQE, CQA, CMQ/OE) or equivalent certifications are desirable.
Staff Quality Specialist in Remote at Unknown Company
This position is listed as full time and onsite.