Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, Business Administration, or a related field; advanced degree preferred.
7+ years of experience in Quality Systems, Quality Assurance, Regulatory Affairs, Compliance, Process Excellence, or related areas within the medical device industry.
Proven track record in developing and implementing controlled quality system documentation such as procedures and work instructions.
Experience in QMS harmonization, remediation, or continuous improvement initiatives across multiple functions and regions.
Strong understanding of QMS subprocesses and relevant regulatory standards, including ISO 13485 and FDA QSR.
Responsibilities
Review and harmonize quality system documentation across QMS subprocesses.
Identify and evaluate opportunities for process simplification and standardization.
Develop revisions for scalable global processes while ensuring compliance.
Collaborate with stakeholders to define future-state workflows and roles.
Facilitate cross-functional sessions for requirement gathering and consensus building.
Support quality system transformation and continuous improvement projects.
Document recommendations and decisions for management reviews and stakeholder approvals.
Benefits
Opportunity to influence global QMS harmonization and improvement efforts.
Collaborative cross-functional working environment.
Involvement in quality system transformation and compliance initiatives.
Professional development through engagement with regulatory standards and quality frameworks.
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.
