Job Description 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

Job Description

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).
 Supports quality initiatives for plant issues.

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift