Job Description

Department Details
Role Summary
PRIMARY RESPONSIBILITIES:

• Ensures that designs meet regulatory requirements, quality standards, and company policies throughout the product lifecycle (FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, ISO 14971)
• Review design documentation, specifications, and data to identify potential compliance gaps and quality issues.
• Responsible for developing and implementing compliance programs, identifying potential issues, and recommending corrective actions to ensure product safety, reliability, and efficacy.
• Maintain accurate and up-to-date documentation related to compliance activities, including test results, reports, and procedures.
• Hands-on experience in Design History File compilation / Technical file documentation.
• Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.
• Possess a strong understanding of design principles, quality control standards, regulatory requirements, and problem-solving methodologies.

Key Responsibilities
PRIMARY RESPONSIBILITIES:

• Ensures that designs meet regulatory requirements, quality standards, and company policies throughout the product lifecycle (FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, ISO 14971)
• Review design documentation, specifications, and data to identify potential compliance gaps and quality issues.
• Responsible for developing and implementing compliance programs, identifying potential issues, and recommending corrective actions to ensure product safety, reliability, and efficacy.
• Maintain accurate and up-to-date documentation related to compliance activities, including test results, reports, and procedures.
• Hands-on experience in Design History File compilation / Technical file documentation.
• Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.
• Possess a strong understanding of design principles, quality control standards, regulatory requirements, and problem-solving methodologies.

Educational Qualifications
Required Education Qualification: B.E
Required Experience: 6 - 12 years