Sr. Quality Engineer

Job Description Summary

Job Description

Job Description number : TCI-JD025

Reporting To : Staff Quality Engineer / Quality Manager

Position Title : Senior Quality Engineer

Job Group : JG3

Department / Segment : Quality Engineering / BD Medical

Location : Bengaluru, India

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 interorganizational

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.

appropriate communication, training, and education of sound quality assurance principles.

assurance responsibilities in a timely, diligent, and professional manner.

Document Title Job Description :

7. Knowledge and Skills :

a. Knowledge

processes, regulatory, and quality requirements.

13485, 21 CFR 820, etc.).

quality tools, continual improvement approaches, industry practices, and

standards.

analysis.

tools, and continual improvement approaches

b. Skills :

both strategic and operational in nature.

8. Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)

Sigma (such as Voice of the Customer, Statistics, Design of Experiments, and Problem

Solving).

Required Skills

Optional Skills

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift

Skills Required

Technical Writing, Iso 13485, design control, Risk Management, Six Sigma