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.
   
    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.

1. 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.

1. 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

.

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift