Sr. Quality Engineer

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.
 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.

Document Title Job Description:
 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:

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

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).

Required Skills

Optional Skills

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