Senior Quality Engineer

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

Job Description

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 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).
  
  

Required Skills

Optional Skills

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift
Skills Required
design for manufacturability , Six Sigma, Statistics, Iso 13485, design control, Risk Management