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.

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