Lead Quality Engineer

Role Overview: As the Lead Quality Engineer, you will be responsible for supporting new product development and product maintenance for medical devices by applying your Quality engineering skills. You will be involved in handling projects from product inception through launch and maintenance, ensuring that products meet quality standards in alignment with Corporate and unit policies, as well as regulatory requirements. Key Responsibilities: - Support design control projects. - Write and lead risk management activities. - Assist in creating specifications, design, and test methods for new products. - Translate customer needs into engineering requirements for product, packaging, and process specifications. - Write detailed technical reports for design verification analysis/testing. - Collaborate with manufacturing to ensure the manufacturability of design solutions. - Apply technical principles, theories, concepts, and quality sciences/tools consistently. - Solve problems effectively. - Ensure that all design control and production/process control projects meet regulatory requirements. - Represent Quality on new product development and sustaining engineering projects. - Review and approve new and modified design/process specifications. - Assist in supplier and internal quality system audits. - Support implementation of new products, processes, and changes by developing quality plans and validation protocols. - Participate in manufacturing and quality process improvement projects using Continuous Improvement and Six Sigma tools. - Analyze inspection and process data to identify quality problems and improvement opportunities. - Investigate, document, and take corrective actions for deviations, non-conforming material, and customer complaints. - Conduct Internal and Supplier Audits and provide audit support for customer and regulatory audits. - Provide training on best practices for operations and engineering teams. - Communicate effectively across functions/departments. - Ensure compliance with safety regulations and procedures. Qualifications Required: - Good working knowledge of medical device regulations and practices (ISO13485, ISO 14971, FDA, 21CFR820 Quality System Regulation, etc.) - Understanding of QA principles, concepts, and industry practices. - Extensive knowledge in Design Control principles. - Experience in Risk management activities. - Proven understanding of statistical concepts. - Knowledge of applicable regulatory requirements. - Experience in design of experiments and statistics. - Class II / III medical device experience. - Knowledge of six sigma methodology (preferred). - ASQ certified quality engineer (CQE) or certified quality auditor (CQA) (preferred). Additional Company Details: The company is located in IND Bengaluru - Technology Campus.,