Sr. Quality Engineer

American medical equipment company.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Responsibilities

Initiate and lead in the investigation of highly complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles, analyze results, make recommendations and develop reports, based on engineering principles; Drive the development and manage the execution of multiple, highly complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles, analyze results, make recommendations, and develop reports and lead team members to drive project completion; Lead in the identification and ensure the optimization of highly complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods ) for design for manufacturing and for continuous process improvement . Identify opportunities for re-design/design of highly complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

Requirements

Bachelor's degree required; Minimum of 8 years of experience; Minimum of 3 years of experience in medical device industry