Quality Control Engineer

ob Description – Quality EngineerPosition: Quality Engineer

Industry: Medical Device / Pharma Device Manufacturing

Experience: 3–5 Years

Qualification: B.E./B.Tech in Mechanical Engineering

Salary: ₹4.8–7.2 LPA (₹40,000–₹60,000 per month)

Job SummaryWe are looking for a Quality Engineer with experience in the medical device manufacturing industry. The ideal candidate should have hands-on experience in quality assurance, regulatory documentation, and CDSCO compliance to ensure products meet applicable quality and regulatory standards.

• Key ResponsibilitiesPrepare, review, and maintain CDSCO documentation and regulatory records.
• Ensure compliance with applicable Quality Management System (QMS) requirements.
• Conduct incoming, in-process, and final product quality inspections.
• Prepare and maintain SOPs, quality records, and validation documents.
• Handle CAPA, NCR, deviations, and customer complaints.
• Coordinate internal audits and support external regulatory audits.
• Perform root cause analysis and implement corrective and preventive actions.
• Work closely with production, R&D, and regulatory teams to maintain product quality.
• Ensure compliance with ISO 13485, GMP, and other applicable quality standards.
• Required SkillsStrong knowledge of CDSCO documentation and regulatory requirements.
• Experience in Quality Assurance within a medical device manufacturing environment.
• Good understanding of ISO 13485, GMP, and quality systems.
• Proficiency in documentation, problem-solving, and root cause analysis.
• Good communication and coordination skills.
• Preferred Candidate ProfileMechanical Engineer with 3–5 years of relevant experience.
• Experience in medical device or pharma device manufacturing is mandatory.
• Ability to work independently and manage quality documentation effectively.