As a Lead Engineer - Quality, responsibilities are:
• Create and maintain Quality Management Plan for the assigned project(s).
• Prepare and conduct the Quality Gates / Main reviews for the defined milestones of assigned project(s).
• Ensure compliance of products with legal and normative requirements
• Report Project Quality status to the Management and Partners and escalate on time when there is a need.
• Collect the Metrics defined for the project and analyze using statistical methods to derive improvement opportunities and trigger necessary actions in order to achieve Business goals with continuous improvements.
• Consulting, training and support for the project team in respect to quality and process topics in order to adhere to defined Processes.
• Drive lean / agile practices
• Support audits and inspections by external bodies and support on the auditing of suppliers regarding regulatory issues.
Qualification: B.E. / B.Tech / M.C.A / M.E. / M. Tech / Post graduate degree with Statistics/Mathematics
Experience: Over 10 years of experience in the area of Process Quality Assurance
• In-depth knowledge of Quality Management system and requirements - experience in implementation of QMS in the Projects.
• In-depth knowledge on Standards and Regulations i.e. ISO 9001, 13485, FDA, MDD
• Experience in healthcare domain is desired
• Good Knowledge of metrics and Statistical analysis
• Experience in facing and conducting Audits as required
• Experience in managing a team is desirable
• Should have good Moderation and Presentation skills
• Good analytical and problem-solving skills
• Ability to effectively communicate and interact with different stakeholders of the project organization and product teams
• Proactive, self-motivated, result oriented, good oral and written communication