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 workplace.
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
Solid 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
Robust 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.