Job Description – QMS Executive
Job Title: QMS Executive
Department: Quality Assurance
Reports To: Quality Manager / Head – Quality
Job Summary
The QMS Executive is responsible for implementing, maintaining, and improving the organization's Quality Management System in compliance with applicable regulatory requirements and quality standards. The role ensures that quality processes are effectively documented, monitored, and continuously improved to support operational excellence and customer satisfaction.
Key Responsibilities
- Maintain and update Quality Management System documentation, including SOPs, work instructions, policies, and records.
- Coordinate internal and external quality audits and support audit readiness.
- Monitor corrective and preventive actions (CAPA) and ensure timely closure.
- Manage document control, change control, and record retention activities.
- Track non-conformities, customer complaints, and deviations, and support root cause analysis.
- Prepare and maintain quality metrics, reports, and management review documentation.
- Conduct employee training on QMS procedures and quality standards.
- Support supplier quality management, qualification, and performance monitoring.
- Participate in risk management and continuous improvement initiatives.
- Ensure compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), where applicable.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a related field.
- 1–3 years of experience in Quality Assurance or Quality Management Systems, preferably in the medical device or healthcare industry.
- Knowledge of ISO 13485, ISO 9001, CAPA, document control, risk management, and audit processes.
Skills
- Excellent documentation and organizational skills.
- Good communication and interpersonal skills.
- Attention to detail and accuracy.
- Ability to work independently and as part of a cross-functional team.
Preferred
- Experience with regulatory inspections and quality audits.
- Familiarity with medical device regulatory requirements and quality tools.
Pay: ₹15,000.00 - ₹20,000.00 per month
Work Location: In person