Staff Quality Specialist

Job Title: Staff Quality Specialist
Location: 100% Remote (Parsippany, NJ)
Duration: 12 -month contract

Overview:
The Staff Quality Specialist shall evaluate existing quality system procedures, work instructions, forms, templates, and related documentation across multiple quality subprocesses; identify opportunities for simplification and alignment; and develop consolidated, future-state global processes that improve consistency, efficiency, compliance, and user adoption. This position will partner with cross-functional stakeholders to assess current-state processes, facilitate process redesign activities, redline and harmonize controlled documentation, and support implementation of globally standardized quality system processes.

RESPONSIBILITIES:

• Review, assess, and harmonize quality system procedures, work instructions, forms, templates, and related controlled documentation across multiple Quality Management System (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 that support a single, scalable global process while maintaining compliance with applicable regulations and quality standards.
• Partner with process owners and subject matter experts to define future-state workflows, roles, responsibilities, decision points, and required controls.
• Analyze interactions and dependencies between QMS subprocesses, including but not limited to 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 activities.
• 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 as assigned by the Manager, Strategy & Improvement.
• Support implementation readiness activities including impact assessments, training needs analysis, communication planning, and deployment support for newly approved processes.
• Provide expertise on quality system documentation architecture, procedural hierarchy, and document standardization to improve consistency across the organization.
• Identify opportunities to reduce procedural complexity, improve user adoption, and increase efficiency while maintaining appropriate quality and regulatory controls.

EXPERIENCE & EDUCATION:

• Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, Business Administration, or a related discipline required; advanced degree preferred (MBA, MS, or equivalent).
• Minimum of 7 years of experience in Quality Systems, Quality Assurance, Regulatory Affairs, Compliance, Process Excellence, or a related function within the medical device industry.
• Demonstrated experience developing, reviewing, revising, and implementing controlled quality system documentation, including procedures, work instructions, forms, templates, and process-related documentation.
• Proven experience leading or supporting Quality Management System (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 to identify opportunities for simplification, standardization, and compliance improvements.
• Strong understanding of quality system subprocesses, including but not limited to Change Control, Document Control, CAPA, Nonconformance Management, Training, Audits, Supplier Quality, Design Controls, Risk Management, Validation, Complaints, and Management Review.
• Working knowledge of applicable regulatory and quality system requirements, including ISO 13485, FDA Quality System Regulation/QMSR requirements, EU MDR, and other global quality standards.
• Demonstrated success facilitating cross-functional workshops, driving stakeholder alignment, and translating business and compliance requirements into practical, scalable process solutions.
• Experience with electronic Quality Management Systems (eQMS), Product Lifecycle Management (PLM) systems, document management systems, and Microsoft Office applications preferred.
• ASQ certifications (CQE, CQA, CMQ/OE) or equivalent professional certifications are desirable.

KNOWLEDGE, SKILLS AND ABILITIES:

• Advanced knowledge of Quality Management System (QMS) principles, quality system architecture, and the interrelationships between key quality subprocesses, including Document Control, CAPA, Nonconformance Management, Change Control, Training, Supplier Quality, Audits, Risk Management, Design Controls, Validation, Complaints, and Management Review.
• Strong understanding of global regulatory and quality standards, including ISO 13485, FDA Quality System Regulation (QSR/QMSR), EU MDR, and applicable quality compliance requirements.
• Demonstrated ability to review, analyze, simplify, and harmonize complex procedures, work instructions, forms, templates, and controlled documentation into scalable global processes.
• Exceptional technical writing, editing, and redlining capabilities with the ability to create clear, concise, compliant, and user-friendly procedural documentation.
• Strong process mapping and business process analysis skills with the ability to identify inefficiencies, redundancies, gaps, and opportunities for standardization and continuous improvement.
• Ability to translate regulatory requirements, business needs, and stakeholder input into practical, implementable quality system solutions.
• Excellent facilitation and stakeholder management skills with experience leading workshops, driving alignment, and building consensus across cross-functional and global teams.
• Strong analytical and problem-solving skills with the ability to independently evaluate complex process issues, assess impacts, and recommend effective solutions.
• Experience supporting quality system transformations, remediation activities, process harmonization initiatives, mergers/integrations, or enterprise-wide improvement programs.
• Strong organizational skills with the ability to track decisions, action items, requirements, risks, and dependencies across multiple subprocesses and stakeholders.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Visio, and collaboration platforms such as SharePoint and Teams.
• Working knowledge of electronic Quality Management Systems (eQMS), Product Lifecycle Management (PLM) systems, document management systems, and workflow-based quality applications.
• Ability to work independently with minimal supervision while effectively communicating progress, risks, recommendations, and escalation needs to leadership.
• Strong continuous improvement mindset with the ability to challenge existing practices, drive process simplification, and promote global standardization while maintaining compliance.
• Effective verbal and written communication skills with the ability to communicate technical and quality system concepts to both technical and non-technical audiences.
• High level of professionalism, integrity, collaboration, and accountability in a regulated environment.

PREFERRED COMPETENCIES

• Quality System Harmonization & Standardization
• Process Excellence & Continuous Improvement
• Technical Writing & Documentation Management
• Cross-Functional Facilitation
• Business Process Analysis & Process Mapping
• Root Cause Analysis & Risk Assessment
• Change Management & Organizational Readiness
• Regulatory Compliance & Inspection Readiness
• Project Coordination & Stakeholder Management
• Global Quality Systems Transformation Initiatives