Senior Quality Engineer

Becton Dickinson; Bengaluru; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Becton Dickinson is seeking a Quality Assurance professional in Bengaluru to lead and improve quality systems for R&D. The ideal candidate will have 4-9 years of experience and a Bachelor's degree in mechanical or biomedical engineering.

You will ensure compliance with quality policies and support the design control process while applying Six Sigma methodology to enhance product development. This role requires strong technical expertise and effective collaboration within cross-functional teams.

Qualifications

• 4-9 years of relevant experience in quality assurance.
• Strong understanding of design control and quality management systems.
• Experience in applying Six Sigma methodology.

Responsibilities

• Develop and improve quality systems for R&D in compliance with 21 CFR 820.
• Ensure compliance with quality policies and provide training.
• Lead risk management plans and promote statistical methods.

Skills

Quality assurance

Statistical techniques

Six Sigma methodology

Design control

Risk Management

Education

Bachelor's degree in mechanical engineering or biomedical engineering

Job description

Job Description Summary

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.

Educational Background

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

Professional Experience

4-9 years of relevant experience.

Primary 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 associates in related technical roles.
• Provides technical direction and frequent feedback.
• Participates and assists in their success.
• Contributes to assembly and maintenance of the Design History File (DHF).

Location

• Bengaluru - Technology Campus (Primary)