Job Description

Role – QMS & Training Manager / Lead
The QMS & Training Manager/Lead is responsible for leading and maintaining the organization's Quality Management System (QMS) and Training Management Program to ensure compliance with global regulatory and quality standards. The role oversees quality processes, document control, training governance, audit readiness, quality metrics, and continuous improvement initiatives.
The individual will act as the subject matter expert for QMS and training compliance, partnering with cross-functional teams to ensure adherence to regulatory requirements including ISO 13485, FDA 21 CFR Part 820, EU MDR, and applicable international standards.

Key Responsibilities:
Quality Management System Leadership
Lead the development, implementation, maintenance, and continuous improvement of the Quality Management System.
Ensure compliance with applicable regulations and standards, including:
EN ISO 13485
IMDR
FDA 21 CFR Part 820 / QMSR
EU MDR 2017/745
Other applicable global regulations & Standards
Establish and maintain QMS governance, procedures,



and quality policies.
Drive quality culture and operational excellence across the organization.

QMS Process Ownership
Oversee key quality system processes including:
Document Control
Change Control
Quality Manual / Quality Plans
Internal and External Audits / Inspections
Management Review
Training Management
Ensure processes remain compliant, effective, and inspection-ready.

Training Program Management
Own the corporate training compliance program.
Develop and maintain role-based training matrices.
Ensure regulatory, quality, and job-specific training requirements are assigned and completed on time.
Manage Learning Management Systems (LMS) and electronic training records.
Monitor training effectiveness and identify competency gaps.
Collaborate with functional leaders to establish learning and development plans.
Audit & Inspection Readiness
Lead internal audit programs and quality compliance

📌 Manager Quality Management (Ahmedabad)
🏢 Zydus Group
📍 Ahmedabad