Quality & Compliance Specialist

The main responsibility of this role is to ensure that all project deliverables meet internal Quality Management System (QMS) standards, defined templates, and Critical to Safety (CTS)/Critical to Quality (CTQ) quality gates before submission. This involves reviewing Design History File (DHF) documents for completeness, consistency, and QMS compliance, as well as performing CTS and CTQ checks across documentation. Additionally, supporting traceability between user needs, product requirements, and verification/validation is essential. Another key aspect of the role is monitoring changes to QMS procedures/templates and managing any resulting documentation updates. Collaboration with Regulatory Affairs (RA) and Risk teams is required to maintain documentation integrity. The ideal candidate for this position must be based in Pune, India, or willing to relocate. Furthermore, they should be available to work until 12:00 PM Eastern Time (ET) to facilitate collaboration with US-based teams. Qualifications for this role include at least 4-6 years of experience in Quality Assurance or Regulatory Compliance within the medical devices industry. The candidate should possess a strong knowledge of QMS frameworks, design controls, and documentation audits. Detail-oriented individuals with experience in checklist-based review processes are preferred for this position.,