Job Category: IT

Job Type: Full Time

Job Location: Hyderabad

Total Experience

10+ Years

Relevant Experience

5–8 Years in QMS Compliance & Administration

Preferred Certifications

- CIS – Risk & Compliance / Vendor Risk / Audit Management / BCM
- CSA – ServiceNow Certified System Administrator
- CAD – Certified Application Developer

Role Overview

We are seeking a QMS Compliance Specialist II (Manager Level) to support Quality Management System (QMS) integration, compliance, and continuous improvement initiatives in a regulated setting.

Key Responsibilities

- Assess QMS gaps against standards like ISO 13485 and 21 CFR 820 (QMSR)
- Develop and maintain SOPs, work instructions, and quality documentation
- Support QMS integration during mergers, acquisitions, and system migrations
- Perform gap assessments between legacy and target QMS systems
- Standardize processes, templates, and documentation
- Support eQMS implementation, migration, and validation
- Provide quality guidance to project teams
- Support management reviews and CAPA boards




- Apply risk-based thinking for compliance and product quality
- Act as change analyst for QMS and non-QMS processes

Technical Skills

Must Have

- 6–10 years in QMS Administration / Quality Systems
- Strong knowledge of:
- ISO 13485
- FDA regulations (21 CFR 820)

- Experience with QMS processes & compliance frameworks
- Proficiency in:

- MS Office (Excel, Word, PowerPoint)
- SharePoint

- Strong analytical and problem-solving skills
- Ability to work independently

Nice to Have

- ISO 13485 Lead Auditor Certification
- Audit management experience
- Exposure to eQMS platforms & system validation

Qualifications

- Bachelor’s Degree in Engineering (B.Tech preferred)

Soft Skills

- Strong communication & stakeholder management
- Analytical thinking & problem-solving
- Attention to detail
- Ability to work independently and in teams

After you submit your application, our team will evaluate your profile and get back to you with an update.

📌 Architect Manager Lead (QMS Compliance Specialist) (India)
🏢 D-TechWorks
📍 India