| 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 environment.
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
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