Location : Hyderabad.

Experience : 10+ Years.

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.

Key Responsibilities :

- 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.

Required Expertise :

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.