Primary Responsibilities

• 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).