QA/QC Engineer

Job Description – QA & QC Engineer (Medical Devices)Position Summary

The QA & QC Engineer is responsible for ensuring that all medical devices meet quality standards, regulatory requirements, and organizational policies. The role involves implementing quality systems, performing inspections, conducting audits, and supporting regulatory submissions to ensure safe and effective products are delivered to the market.

Key Responsibilities

• Quality Assurance
• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
• Conduct internal audits, CAPA (Corrective & Preventive Action), and risk assessments to ensure ongoing compliance.
• Monitor production processes and verify adherence to SOPs, specifications, and quality standards.
• Quality Control
• Perform in-process inspections, final product testing, and release of products.
• Review and approve batch records, test reports, and other QC documentation.
• Manage calibration and preventive maintenance schedules for testing and measuring instruments.
• Investigate non-conformities and implement corrective actions.
• Regulatory Compliance
• Ensure compliance with national and international medical device regulations (FDA, CDSCO, CE, ISO).
• Support preparation of regulatory submissions (510(k), PMA, CE Marking, etc.).
• Communicate with regulatory authorities to resolve compliance issues.
• Process Improvement
• Identify areas of process improvement to enhance product quality and operational efficiency.
• Implement Lean Six Sigma/continuous improvement methodologies to reduce defects and improve productivity.
• Supplier Quality Management
• Conduct supplier audits and ensure raw material/component quality.
• Collaborate with vendors for corrective actions and quality improvement initiatives.
• Documentation & Reporting
• Prepare and maintain technical files, Device Master Records (DMR), and Device History Records (DHR).
• Maintain up-to-date documentation to support internal audits, external inspections, and certifications.
• Generate quality reports and present trends to management for decision-making.

Required Skills & Knowledge

• Strong understanding of QA/QC principles in the medical device industry.
• Knowledge of ISO 13485, ISO 14971, GMP, and FDA 21 CFR Part 820.
• Hands-on experience with quality audits, validation, and verification processes.
• Familiarity with regulatory submissions and compliance requirements.
• Excellent documentation, analytical, and problem-solving skills.
• Ability to train and guide cross-functional teams on quality and compliance.
• Mob No 9266682964

Job Types: Full-time, Permanent

Pay: ₹15,159.32 - ₹35,189.82 per month

Benefits:

• Cell phone reimbursement
• Health insurance

Work Location: In person

Speak with the employer
+91 9266682964