Job Title

Primary Function: Ensures all project deliverables meet internal QMS standards, defined templates, and CTS/CTQ quality gates before submission. Key Responsibilities: · Review DHF documents for completeness, consistency, and QMS compliance · Perform CTS (Critical to Safety) and CTQ (Critical to Quality) checks across documentation · Support traceability between user needs, product requirements, and verification/validation · Monitor changes to QMS procedures/templates and manage any resulting documentation updates · Collaborate with RA and Risk teams to maintain documentation integrity Location Requirement: Candidate must be based in Pune, India or willing to relocate. Working Hours Requirement: ⏰ Candidate must be available to work until 12:00 PM Eastern Time (ET) to enable collaboration with US-based teams. Qualifications: · 4–6 years in Quality Assurance or Regulatory Compliance within medical devices · Strong knowledge of QMS frameworks, design controls, and documentation audits · Detail-oriented with experience in checklist-based review processes