Quality Engineer I

Posting Date: 05/09/2019
Closing Date: 06/09/2019
Posting Level: Entry Level

Position Summary:

The Quality Engineer is responsible for improving quality, production, and processing methods and controls in manufacturing to achieve operational excellence. This position requires the ability to build and maintain strong relationships with manufacturing engineering, material planning, and production, to work and communicate across various levels of the organization. This position, under the direction of the Senior Product Quality Manager, works closely with R&D, Supply Chain Management, and Manufacturing to support the day-to-day operations. The role be integral in the process validation of new products as they move through development and into production.

Principal Responsibilities:

•Determine test requirements, test methods, sample sizes and statistical analysis for qualification/verification studies for manufacturing.
•Develop verification, validation and qualification plans and reports for manufacturing.
•Initiate and lead non-conformance investigations regarding component failures, finished goods failures, and product returns. This includes but is not limited to performing risk analysis, determining root cause and recommending corrective action.
•Coordinate the Change Impact Assessment activities.
•Processes manufacturing process defects through nonconformance process.
•Provides feedback to update SOPs and other documentation.

Education / Experience Requirements:

•BA/BS in Engineering or physical sciences required.
•No related experience required.

Specialized Skills / Other Requirements:

•Demonstrates a general understanding of functional area.
•Limited understanding of the quality system and regulatory compliance.

Keep your finger on the pulse of Medical Alley from anywhere with the ALLEY NEWSLETTER