QMS System Lead –Mgmt Control

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 & Dev Ops,
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 :

• Serve as the Subject Matter Expert (SME) for Management Control processes, providing guidance on regulatory compliance, best practices, and systemic improvements.
• Lead the Management Control Workstream within the QMS remediation program to address compliance gaps and enhance system-level controls.
• Support CAPA investigations and remediation activities, including root cause analysis, risk including root cause analysis, risk
• Implement and monitor interim controls and risk mitigation measures to maintain compliance until permanent solutions are validated and executed.
• Lead or support the redesign, remediation, and implementation of Management Control procedures, tools, and records, ensuring alignment with global regulatory standards.
• Develop and maintain metrics, dashboards, and reporting mechanisms to monitor remediation progress, effectiveness, and continuous improvement opportunities.
• Provide training, mentorship, and cross-functional guidance to ensure proper adherence to Management Control processes and strengthen organizational quality culture.

Candidate requirements:

• Bachelor’s degree in a technical or scientific discipline (or equivalent experience in quality systems within a regulated industry).
• 8+ years of experience in Quality Management Systems, preferably in the medical device
• Deep expertise in management control processes, tools, and regulatory compliance.
• Demonstrated knowledge of FDA 21 CFR 820, ISO 13485, and other relevant global quality regulations.
• Experience supporting QMS remediation initiatives, audits, inspections, or enforcement actions related to management controls.
• Strong analytical, technical writing, and communication skills, including ability to deliver executive-level updates and regulatory-ready documentation.
• Proven ability to lead cross-functional teams and manage multiple work streams, driving remediation and sustainable compliance.