Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred.
7+ years of experience in Quality Systems or related functions in the medical device industry.
Proven track record in developing and revising quality system documents.
Experience in leading QMS harmonization and continuous improvement initiatives.
Strong knowledge of relevant regulatory standards like ISO 13485 and FDA QSR.
Proficient in process mapping and conducting gap analyses.
Familiarity with eQMS and PLM systems.
Responsibilities
Review and harmonize quality system procedures and related documentation.
Identify opportunities for simplification and standardization in current processes.
Develop redlined revisions for scalable global processes while ensuring compliance.
Collaborate with stakeholders to define future-state workflows and responsibilities.
Analyze dependencies across various QMS subprocesses to enhance interaction and compliance.
Support the creation of aligned procedures, templates, and training materials.
Facilitate sessions to gather requirements and resolve process conflicts.
Document recommendations and implementation considerations to assist management review.
Benefits
Opportunity to lead quality system transformation initiatives.
Collaborative work with cross-functional teams.
Contribution to global standardization efforts.
Engagement with cutting-edge regulatory compliance processes.
Full 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.
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.
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.
SQ certifications (CQE, CQA, CMQ/OE) or equivalent certifications are desirable.
