Lead Quality Engineer

Job Description Summary As directed by the Quality Manager, the Lead Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stated objectives. Job Description Primary Responsibilities • Support design control projects. • Writes and leads risk management activities. • Support the efforts in creation of specifications, design, and test methods for the new products. • Translate customer needs into engineering requirements into specific product, packaging and process specifications. • Write detailed technical reports based on design verification analysis/testing for design changes and product design activities • Interface with manufacturing on an ongoing basis during the development stages to ensure manufacturability of the design solutions. • Consistent application of technical principles, theories, concepts, and quality sciences / tools. • Proven problem-solving skills • Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements. • Is a team member representing Quality on new product development and sustaining engineering projects. • Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc. • Assists with supplier and internal quality system audits as a means of evaluating the efficiency of the established Quality System and Good manufacturing Practices. • Support the implementation of new products, processes, and changes by developing quality plans, approval of validation plans and protocols, inspection methods, work instructions, and raw material specifications and inspection plans. • Support manufacturing and quality process improvement projects as an effective team member or leader using Continuous Improvement and Six Sigma tools. • Analyse and interpret inspection and process data to identify and prevent quality problems and continuous improvement opportunities. • Responsible for the investigation, documentation, root cause, and corrective action activities of deviations and non-conforming material. • Responsible for the investigation, documentation, root cause, and corrective action activities of customer complaints. • Conduct Internal and Supplier Audits. Provide audit support for customer and regulatory audits (preparation, closure, etc.) • Provides training for operations and engineering teams or best practices. • Communicates across functions / departments for assigned areas of responsibility. • Comply with all local, state, federal, and BD Safety regulations, policies, and procedures including RCRA Hazardous waste regulations Required Skills Optional Skills . Primary Work Location IND Bengaluru - Technology Campus Additional Locations Work Shift BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.