Senior Quality Engineer

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.

Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stated objectives.

Job Description

Educational Background

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

Professional Experience

4-9 years of relevant experience

Job Responsibilities

• Support design control projects.
• Writes and leads risk management activities.
• Support the efforts in creation of specifications, design, and test methods for the new products.
• Translate customer needs into engineering requirements into specific product, packaging and process specifications.
• Write detailed technical reports based on design verification analysis/testing for design changes and product design activities
• Interface with manufacturing on an ongoing basis during the development stages to ensure manufacturability of the design solutions.
• 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.

Knowledge and Skills

Knowledge

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

Skills

• 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 (Not essential to the job but will be an advantage to possess)

• 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).

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift