Senior Quality Engineer (4+)
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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