Senior Quality Engineer

Overview

Senior Quality Engineer role supporting quality assurance activities, quality systems and design control for medical device development at BD Technology Campus India in Bengaluru.

What you'll do

• Lead or assist in developing and continuously improving quality systems for R&D in compliance with 21 CFR 820, ISO 13485 and EN requirements, with a focus on design control.
• Ensure compliance with BD quality policies, procedures and practices through communication, training and education in sound quality assurance principles.
• Contribute as a team member on development projects, carrying out assigned quality assurance responsibilities in a timely, diligent and professional manner.
• Promote an advanced understanding of customer needs and processes to ensure relevant and innovative product development.
• Apply Design to Cost and Design for Manufacturability methods to support the project leader in achieving project objectives.
• Support cross-functional planning, coordination and reviews.
• Lead Risk Management plans, reports and situational analyses for products under design authority.
• Promote the use of statistics in the testing and control of quality and apply Six Sigma methodology to support the product development process.
• Actively mentor associates in related technical roles, providing technical direction and frequent feedback.
• Contribute to assembly and maintenance of the Design History File (DHF).
• Support quality initiatives for plant issues.

What you'll need

• Bachelor's degree in mechanical engineering, biomedical engineering, or a related engineering discipline.
• 4-9 years of relevant experience.
• 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.

Nice to have

• Master's degree in a related engineering discipline.
• Certified Quality Engineer (CQE) and/or Six Sigma Green/Black Belt.
• Knowledge of engineering performance enhancement tools in Design for Six Sigma (such as Voice of the Customer, statistics, Design of Experiments and problem solving).

Details

• Primary work location: Bengaluru, India (Technology Campus).