Senior Quality Engineer

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description About BD: 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 develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

About BD TCI: “BD, a 125-year-old global medical device company has started its Enterprise Center in Bangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be an integral part of the global network for BDX. It will have presence of R&D, Quality, Regulatory, IT and other functions. The center boasts of some of the brightest minds who work in a unique environment that fosters and supports ingenuity. BD TCI is dedicated to serving BD’s customers and patients thereby contributing its bit towards “advancing the world of health”.

Position Summary: Performs a variety of quality assurance activities to ensure successful completion of projects or aspects of large programs. Applies technical expertise and knowledge of advanced statistical techniques to support engineering work in the design, development, and evaluation of medical devices. Supports development and successful implementation of quality systems and procedures. Supports maintenance and expansion of QMS as required. Frequent interorganization contacts on technical matters often requiring coordination between organizations.

Educational Background: Bachelor’s degree in mechanical engineering, biomedical engineering, or related engineering discipline.

Professional Experience: 4-9 years of relevant experience

Job Responsibilities:  Leads or assists in the development of, and continuous improvement of, quality systems for R&D in compliance with 21 CFR 820, ISO 13485 and EN requirements with specific focus on design control.  Ensures compliance with BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.  Contributes as a team member on development projects carrying out assigned quality assurance responsibilities in a timely, diligent, and professional manner.  Promotes advanced understanding of customer needs and processes to ensure relevant and innovative product development.  Applies Design to Cost and Design for Manufacturability methods to support project leader in achievement of project objectives.  Supports cross-functional planning, coordination, and reviews.  Leads Risk Management plans/ reports and situational analyses for products under design authority.  Promotes the use of statistics in the testing and control of quality. Applies Six Sigma methodology to support product development process.  Actively mentors associate in related technical roles. Provide technical direction and frequent feedback. Participate and assist in their success.  Contributes to assembly and maintenance the Design History File (DHF).  Supports quality initiatives for plant issues.

Knowledge and Skills:  Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements.  Good working knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, etc.).  Complete understanding of quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards.  Advanced knowledge of Six Sigma methodology, statistical methods and analysis.  Ability to translate customer needs into design inputs and specifications.  Good knowledge and understanding of process development, total quality tools, and continual improvement approaches.  Excellent Project Management and technical writing skills.  Strong critical thinking, analytical, and problem-solving skills.  Ability to prioritize and multi-task many different forms of work input that are both strategic and operational in nature.

Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess):  Master’s degree in related engineering discipline.  Certified Quality Engineer (CQE) and/or Six Sigma Green/ Black Belt.  Knowledge of engineering performance enhancement tools in the area of Design for Six Sigma (such as Voice of the Customer, Statistics, Design of Experiments, and Problem Solving).

Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills

. Primary Work Location IND Bengaluru - Technology Campus

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