Quality & Compliance Specialist

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