Job Title: Quality Engineer
Location: Mumbai
Experience: 3–5 Years
Qualification: B.E./B.Tech in Mechanical Engineering
Job Type: Full-Time
Job Summary
We are looking for a detail-oriented and experienced Quality Engineer with strong expertise in CDSCO Documentation and quality management systems. The ideal candidate should have a Mechanical Engineering background and hands-on experience in preparing, reviewing, and maintaining regulatory documentation for medical devices. Candidates with experience in quality assurance, compliance, audits, and process improvement will be preferred.
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 Manufacturing Industry will be preferred.
- Candidates having exposure to regulatory compliance and quality audits will be given preference.
Preferred Industry
- Medical Devices
- Medical Equipment
- Healthcare Manufacturing
- Surgical Instruments
- Biomedical Manufacturing
Why Join Us?
- Opportunity to work with a growing Medical Device organization.
- Exposure to regulatory compliance and quality management systems.
- Career growth with a professional and collaborative work environment.
- Competitive salary and employee benefits.
Pay: ₹30,000.00 - ₹50,000.00 per month
Benefits:
- Paid sick time
- Paid time off
Work Location: In person
