Global QMS Harmonization Specialist

JobDiva, Inc.; Parsippany-Troy Hills (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

JobDiva, Inc. in Parsippany-Troy Hills, NJ, seeks a Staff Quality Specialist to harmonize QMS procedures, forms, and documentation across subprocesses, driving standardization and regulatory compliance.

This role partners with cross-functional stakeholders to redesign processes and ensure scalable, audit-ready quality systems. The ideal candidate has 7+ years in quality systems within the medical device field, expertise in ISO 13485 and FDA QSR/QMSR, and hands-on experience with eQMS/PLM tools,

Qualifications

• Degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or related field.
• 7+ years in Quality Systems, QA, Regulatory Affairs or related in medical device industry.
• Experience creating and implementing controlled quality system documentation.
• Experience supporting QMS harmonization, remediation, transformation, standardization.
• Knowledge of ISO 13485, FDA QSR/QMSR, EU MDR.
• Experience facilitating cross-functional workshops.

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.

Skills

Quality systems

Regulatory compliance

Process improvement

Cross-functional collaboration

Documentation architecture

Education

Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, Business Administration

MBA or MS preferred

Tools

eQMS

PLM systems

Document management systems

Microsoft Office

Job description

JobDiva, Inc. in Parsippany-Troy Hills, NJ, seeks a Staff Quality Specialist to harmonize QMS procedures, forms, and documentation across subprocesses, driving standardization and regulatory compliance.

This role partners with cross-functional stakeholders to redesign processes and ensure scalable, audit-ready quality systems. The ideal candidate has 7+ years in quality systems within the medical device field, expertise in ISO 13485 and FDA QSR/QMSR, and hands-on experience with eQMS/PLM tools,