Senior Quality Engineer

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

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