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Quality Engineer II - (New Product Development)

Company:
LanceSoft Inc.
Location:
Raynham, Massachusetts, United States
Posted:
April 10, 2019

Description:

Responsibilities:

The Quality Engineer II should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. This individual will work in a design team setting. He/she will support new product development and design through design verification activity. This individual will support design control activities for new product development efforts. This individual will develop risk assessment, inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams. He/she will provide leadership in the understanding of medical device regulations to other disciplines. The Quality Engineer II will be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.

Qualification:

A minimum of a Bachelor's degree in a Technical or Scientific discipline is required. A minimum of 2 years experience is required. An advanced degree in a related field is an asset. Quality Engineering/Process Excellence/Lean experience is preferred. Experience conducting Process / Design Failure Mode Effects and Analysis is an asset. Mechanical product knowledge is preferred. Experience with Blueprint reading/literacy including GD&T is preferred. Familiarity with inspection methods and techniques is an asset. Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred. Excellent problem solving, decision-making skills and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.