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 inter-organization contacts on technical matters often requiring coordination between organizations.

Job Description

Who We Are
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

• 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.
• 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 associates 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.
• Any other tasks as assigned.

• Bachelor's degree in mechanical engineering, biomedical engineering, or related engineering discipline.
• At least 5 years working experience in medical device industry.
• Good working knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, etc.)
• Good knowledge and understanding of process development, total quality tools, and continual improvement approaches.
• Complete understanding of quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards.
• Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements.
• Advanced knowledge of Six Sigma methodology, statistical methods and analysis.
• Ability to translate customer needs into design inputs and specifications.