Job Title: Quality Engineer

Location: Mumbai
Experience: 3-5 Years
Qualification: B.E./B.Tech in Mechanical Engineering

Job Type: Full time

Job Summary

Key Responsibilities
- Prepare, review, and maintain CDSCO documentation as per Indian Medical Device Rules (MDR).
- Ensure compliance with CDSCO, ISO 13485, and applicable regulatory standards.
- Handle technical files, Device Master Files (DMF), Plant Master Files (PMF), and product registration documentation.
- Coordinate with regulatory authorities for approvals, renewals, and compliance activities.
- Conduct internal quality audits and support external regulatory audits.
- Prepare SOPs, Work Instructions, Quality Manuals, and validation documents.
- Monitor CAPA (Corrective & Preventive Actions), NCR, deviations, and customer complaints.
- Perform root cause analysis and implement corrective actions.
- Ensure product quality throughout manufacturing and inspection processes.
- Maintain quality records and documentation in compliance with company standards.
- Work closely with Production, R&D;, Regulatory Affairs,



and Supply Chain teams to ensure product quality and regulatory compliance.
- Support continuous improvement initiatives to enhance product quality and operational efficiency.

Required Skills:
- Strong knowledge of CDSCO Documentation and Medical Device Regulations (MDR).
- Good understanding of ISO 13485, GMP, and Quality Management Systems.
- Experience in regulatory documentation for medical devices.
- Knowledge of CAPA, Internal Audits, Risk Management, and Validation.
- Strong documentation and report-writing skills.
- Good analytical and problem-solving abilities.
- Proficiency in MS Office.
- Excellent communication and coordination skills.

Eligibility Criteria
- Education: B.E./B.Tech in Mechanical Engineering (mandatory)
- Experience: 3-5 years in Quality Engineering
- Hands-on experience in CDSCO Documentation is mandatory.
- Experience in the Medical Devices/Medical Equipment/Healthcare

📌 Quality Engineer (Mumbai)
🏢 NEXTSTEP SOLUTIONS
📍 Mumbai