Manager Quality Management

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, efficient, 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 assessments.
• Support and host external audits conducted by:
• Notified Bodies
• Certification Bodies
• Customers
• Regulatory Agencies
• Drive audit observation remediation and effectiveness verification.
• Ensure inspection readiness across all QMS and training processes.

Metrics, Analytics & Reporting

• Develop and monitor QMS and Training KPIs.
• Prepare quality and compliance reports for management review.
• Analyze trends related to training effectiveness, audit findings, and quality compliance.
• Present quality system performance metrics to senior leadership.

Continuous Improvement

• Identify opportunities for process simplification and automation.
• Lead quality improvement initiatives using Lean, Six Sigma, and risk-based approaches.
• Drive harmonization of quality processes across business functions and global sites.
• Promote best practices and compliance awareness throughout the organization.

Leadership & Stakeholder Management

• Provide leadership, coaching, and development to QMS and Training Processes.
• Partner with Regulatory Affairs, Engineering, Manufacturing, Operations, Clinical Affairs, and HR teams.
• Serve as a trusted advisor on quality system and training-related matters.
• Lead cross-functional quality projects and strategic initiatives.

Education & Qualifications

Required

• Bachelor's Degree in B-Tech , Biomedical Engineering, Biotechnology, Quality Management, or related field.

Preferred

• Master's Degree in Engineering, Regulatory Affairs, or Science
• Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Lean Six Sigma Green Belt/Black Belt, or equivalent certifications.

Experience Required

• 10+ years of experience in Quality Assurance, QMS Management, or Compliance within a regulated industry.
• Strong working knowledge of ISO 13485, FDA QSR/QMSR, EU MDR requirements.
• Experience managing electronic QMS (eQMS) and Learning Management Systems (LMS).
• Proven success in supporting regulatory inspections and external audits.

Technical Competencies

• Quality Management Systems (QMS)
• ISO 13485 & Medical Device Regulations
• Document Control & Change Control
• Internal Auditing & Inspection Readiness
• Training Program Administration
• Learning Management Systems (LMS)
• eQMS Platforms
• Quality Metrics & Data Analytics

Leadership Competencies

• Strategic Leadership
• Cross-functional Collaboration
• Stakeholder Management
• Problem Solving & Decision Making
• Program & Project Management
• Continuous Improvement Mindset

Career Level : Quality Management Systems & Training Manager

Ideal Candidate Profile: A seasoned quality professional with 10+ years of experience managing QMS and training programs in a regulated environment, capable of driving compliance excellence, leading audits and inspections, and building a strong quality culture across the organization.