Senior Quality Engineer

 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.