Posted:1 month ago|
Platform:
On-site
Full Time
Rudhra Info Solutions is a business consulting firm dedicated to delivering customized strategies and solutions. We specialize in innovative solutions for Salesforce, Mulesoft, Tableau, Veeva Vault, AWS, Data Engineering, Big Data, ServiceNow, and SAP. With a team of over 50 Salesforce Certified professionals, we transform businesses through strategic planning, technology implementation, and ongoing support. Our goal is to help clients stay ahead of the curve and maximize their technology investment, ensuring workflow efficiency, data security, and successful adoption of new technologies.
We are looking for highly experienced professionals to join our team as QMS Support. The ideal candidate will bring deep expertise in Quality Management Systems (QMS), regulatory frameworks, and compliance practices to ensure the highest quality standards in our processes.
Serve as the primary expert on Quality Management Systems (QMS), including ISO 9001 and other relevant standards.
Develop, implement, and maintain QMS policies, procedures, and documentation.
Lead internal & external audits; ensure audit readiness and drive corrective actions.
Collaborate with cross-functional teams to ensure compliance across departments.
Provide training & mentorship on QMS principles, tools, and best practices.
Analyze quality data & metrics to identify trends and areas for improvement.
Support risk management, CAPA processes, root cause analysis and participate in management review meetings.
Stay updated on regulatory changes and update QMS documentation accordingly.
In-depth knowledge of ISO 9001, ISO 13485, HIPAA, GxP, FDA regulations.
Strong understanding of:
21 CFR Part 11 & Part 21
Good Manufacturing Practices (GMP)
CSV Regulations
Software as a Medical Device (SaMD)
IEC 62304 & 82304 Regulations
Verification Testing
Penetration Testing & Security
⭐ Why Join Us?
Work on impactful projects in a regulated environment.
Opportunity to collaborate with global teams.
Rudhra Info Solutions
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