Analyst - Design Quality Engineer Biocon Biologics
Biocon Biologics
Office Location
Full Time
Experience: 4 - 4 years required
Pay:
Salary Information not included
Type: Full Time
Location: Karnataka
Skills: mechanical engineering, Product Lifecycle Management, Regulatory Compliance, Quality management, Risk management, Post Market Surveillance, Medical Device Design, Statistical Methods
About Biocon Biologics
Job Description
Job Role : Analyst - Design Quality Engineer A graduate in Mechanical or related engineering and with 4-6 years related medical device /combination product design & development experience and product lifecycle management. 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.,