Job title: QMS System Lead-Doc Control
About Us
Vaisesika is an ISO 27001 certified innovative and value driven company in the business of Software Development, Quality Engineering, Validated Testing, ERP services, Cloud Migration & DevOps, RPA, Data Analytics & Business Intelligence. We have offices in USA, Canada, India and UAE. We have been able to work in multiple projects in various domains ranging from Healthcare & Lifesciences, BFSI, e-commerce, Retail and we pride ourselves as one of the industry leaders in these areas.
Responsibilities
Ø Serve as the Subject Matter Expert (SME) for Document Control processes, providing guidance on regulatory requirements, best practices, and system improvements.
Ø Lead the Document Control Workstream within the QMS remediation program to address compliance gaps and enhance document management systems.
Ø Support CAPA investigations and remediation activities, including root cause analysis, risk assessment, and development of sustainable corrective actions.
Ø Implement and monitor interim controls and risk mitigation measures to maintain compliance until permanent solutions are validated and executed.
Ø Lead or support the redesign, remediation, and implementation of Document Control procedures, systems, and records to ensure alignment with global regulatory standards.
Ø Develop and maintain metrics, dashboards, and reporting tools to monitor remediation progress, document control effectiveness, and continuous improvement initiatives.
Ø Provide training, mentorship, and cross-functional guidance to strengthen adherence to Document Control processes and promote a culture of quality and compliance.
Ø Bachelor’s degree in a technical or scientific discipline, or equivalent experience in quality systems within a regulated industry.
Ø 8+ years of experience in Quality Management Systems, preferably within the medical device industry.
Ø Deep expertise in document control processes, systems, and tools in regulated environments.
Ø Demonstrated knowledge of FDA 21 CFR 820, ISO 13485, and other applicable global regulatory requirements for document control.
Ø Experience supporting QMS remediation initiatives, audits, inspections, or regulatory findings related to document management systems.
Ø Strong analytical, technical writing, and communication skills, capable of preparing regulatory-ready documentation and executive-level updates.
Ø Proven ability to lead cross-functional teams and manage multiple workstreams across sites, driving remediation and sustainable compliance.
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