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.
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
IND Bengaluru - Technology Campus
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
See community guidelines here: https://tinyurl.com/yunjmzkx.
