Senior Quality Engineer

Becton Dickinson; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Becton Dickinson in Bengaluru, India, seeks a QA professional to support design and development of medical devices. The role emphasizes quality systems, regulatory compliance, and continuous improvement in a dynamic RD environment.

You will apply Six Sigma and statistical methods, mentor teammates, and contribute to the DHF while aligning with ISO 13485 and 21 CFR 820 requirements.

Qualifications

• Bachelor's degree in mechanical engineering, biomedical engineering, or related engineering discipline.
• 4-9 years of relevant experience.
• Advanced understanding of design control, regulatory requirements, and quality systems.
• Complete understanding of quality assurance principles and standards (ISO 13485, 21 CFR 820).
• Advanced knowledge of Six Sigma, statistics, and problem-solving techniques.

Responsibilities

• Leads or assists in developing and improving quality systems for R&D in compliance with 21 CFR 820, ISO 13485 and EN requirements (design control).
• Ensures compliance with quality policies through training and education of QA principles.
• Contributes as a team member on development projects, performing QA responsibilities timely and professionally.
• Promotes understanding of customer needs to ensure relevant product development.
• Applies Design to Cost and Design for Manufacturability to support project objectives.
• Supports cross-functional planning, coordination, and reviews.
• Leads Risk Management plans/reports for products under design authority.
• Promotes the use of statistics in testing and control of quality; applies Six Sigma in development.
• Mentors associates in related technical roles; provides direction and feedback.
• Contributes to the DHF and quality initiatives for plant issues.

Skills

Design control

Regulatory knowledge

Six Sigma

Project management

Technical writing

Statistical analysis

Problem solving

Customer needs translation

Education

Bachelor's degree in engineering

Job description

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 interorganization contacts on technical matters often requiring coordination between organizations.

Educational Background

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

Professional Experience

4-9 years of relevant experience

Job Responsibilities

• Leads or assists in the development of, and continuous improvement of, quality systems for RD 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.

Knowledge and Skills

• 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.
• 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.

Desired / Additional Skills Knowledge

• 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

Bengaluru, India

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.