Senior Quality Engineer - Medical Device Company

The Opportunity

Our client is a global medical device company based in Phoenix, AZ. The company is well positioned in numerous commercial product offerings and committed to developing the most cutting edge innovations in medical technology. This company affords its employees exceptional professional growth while providing stability and an enjoyable quality of life.

Job Responsibilities

In this broad-based lead quality engineering role, you will provide quality engineering oversight for product development teams, lead cross-functional teams to develop risk assessments, and write, review and approve design verification and validation protocols and reports. You will perform process improvement, control, and monitoring on manufacturing processes and provide technical direction during design transfer activities. You will coordinate and lead internal and supplier audits and have a role in project planning, budgeting, and scheduling. You will also provide support to the regulatory department in writing technical submissions and provide a positive example and actively promote compliance to all standards.

Required Experience and Education
The right candidate must be detailed in handling information/data, with extensive knowledge of FDA GMP/GLP, Medical Device Directives, ASTM, AAMI, CEN and ISO. A minimum of a Bachelors degree in a technical field is required with specific experience in medical device Quality Assurance (Design Control/Review, Process Validation, and SPC/Process Control skills and experience are all required). Quality Engineering Certification (ASQ) or equivalent is preferred as is formal Six Sixma training.
To Apply Directly
Please send resume to jcompton@agilesearchinc.com








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