Senior Quality Engineer

Job Description Summary

Job Description

1. 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.

2. 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".

3. 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 inter-organization contacts on technical matters often requiring coordination between organizations.

4. Educational Background

Bachelor's degree in mechanical engineering, biomedical engineering, or related engineering discipline.

5. Professional Experience

4-9 years of relevant experience

6. 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.

7. Knowledge and Skills

7.a Knowledge

• 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

7.b Skills

• 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.

8. 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).

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift