Senior QMS Specialist

Summary :
We are seeking a Senior Quality Systems Specialist – Medical Devices (QMS) to support Quality Management System, CAPA remediation, spreadsheet validation, software/Computer System Validation (CSV), and regulatory compliance activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk management, CAPA, change control, document control, and validation processes.

Roles & Responsibilities :

• Review spreadsheet inventories and assess validation requirements in accordance with applicable procedures and quality standards.
• Develop, maintain, and review spreadsheet validation documentation, including Validation Plans, Validation Reports, Risk Assessments, Traceability Matrices, and Impact Assessments.
• Verify spreadsheet controls, formula integrity, access restrictions, document control requirements, and compliance with approved validation procedures.
• Support CAPA corrective action implementation and closure, particularly activities related to spreadsheet remediation and validation.
• Support alignment of local procedures with global requirements for software and spreadsheet validation, change control, and quality system processes.
• Prepare, review, and update controlled SOPs, forms, templates, work instructions, and quality records.
• Conduct gap assessments, risk assessments, and impact analyses to identify compliance issues and recommend corrective actions.
• Coordinate with Quality, Engineering, Manufacturing, Regulatory Affairs, and Document Control teams to obtain reviews, approvals, and timely closure of action items.
• Track project milestones, deliverables, risks, issues, and dependencies and provide regular status updates to project leadership.
• Prepare and maintain CAPA implementation evidence and audit-ready documentation packages.
• Support development of Verification of Effectiveness (VoE) plans, sampling strategies, record reviews, and effectiveness evidence packages.
• Participate in internal audits, compliance assessments, management reviews, and quality system remediation activities.
• Support continuous improvement initiatives to strengthen QMS processes, validation compliance, and regulatory readiness.
• Ensure all deliverables are completed in accordance with applicable company procedures, quality requirements, and project timelines.

Required Experience :

• 4–6 years of relevant experience in Medical Device Quality, Quality Systems, Quality Assurance, Validation, or Regulatory Compliance.
• Demonstrated experience working within a regulated medical device QMS environment.
• Experience with CAPA remediation, spreadsheet/software validation, CSV, risk management, change control, and document control.
• Experience preparing validation and quality documentation and supporting audit/compliance activities.
• Strong experience working with cross-functional teams in a global environment.
• Experience with electronic QMS systems, preferably Greenlight Guru or an equivalent platform.