Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description Summary
Job Description number: TCI-JD026
Reporting To: Staff Quality Engineer / Quality Manager
Position Title: Quality Engineer
Job Group: JG3
Department / Segment: Quality Engineering / BD Medical
Location: Bengaluru, India
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”.
Performs quality assurance activities to ensure compliance with applicable medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Good understanding and frequent application of quality assurance principles, design control concepts, industry practices, and standards. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization and limited outside customer contacts.
Bachelor’s degree in mechanical engineering, biomedical engineering or related engineering discipline.
0-5 years of relevant experience
- Participates in design control activities of medical device products. Ensures proper design and development control and its documentation as per ISO 13485/ FDA QSR Quality System.
- Leads or supports Risk Management in accordance with ISO14971.
- Contributes as a team member on development projects carrying out assigned quality assurance responsibilities in a timely, diligent, and professional manner.
- Creates, implements changes to, and maintains controlled documents as needed (e.g., SOPs, Specifications, Methods, etc.) to ensure strict compliance of R&D functional operation with ISO 13485/ 21 CFR 820 Quality System/ EN requirements.
- Supports continuous improvement of the Quality Systems.
- Applies Statistical tools to support product development process.
- Provides QS knowledge to organization as needed. Administers appropriate training as needed.
- Participates in the ongoing operations of QA/QS activities.
Knowledge and Skills
Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.).
Practical and demonstrated experience of Quality or Reliability engineering, risk analysis, product development and verification/validation testing in the medical device industry.
Demonstrated hands-on experience with Design Control procedures.
Experience in a Phase-Gate development process.
Experience in directly applying statistical methods for quality improvement.
Good knowledge and understanding of process development, total quality tools, and continual improvement approaches.
- Good technical writing skills.
- Familiarity with statistical methods and analysis and/or Minitab software.
- Team player with excellent interpersonal and communication skills.
Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)
- Familiarity with Six Sigma methodology.
- Experience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assemblies.
- Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods).
- Strong critical thinking, analytical, and problem-solving skills.
Any additional Information (Specially if needed for Quality or legal purposes)
- Certified Quality Engineer (CQE)
- Certified Six Sigma Green Belt (SSGB) and/ or Six Sigma Black Belt (SSBB)
Primary Work LocationIND Bangalore - Technology Campus
What makes a successful Engineer Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Team player
Advancing the world of health™
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.