US-CA-Menlo Park: Principal QA Engineer

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Date: 08-Jun-2009

Principal QA Engineer

Requirements

A minimum of a Bachelor's degree in an engineering or related technical discipline with a minimum of 9+ years of experience, or a Master's degree in a technical discipline with a minimum of 7+ years of experience is required. A minimum of 3+ years experience in the medical device industry working on design controls is required. Experience with a statistical package (Minitab or other) is required. Combination Product experience is an asset. Pharmaceutical experience is an asset. Inspection plan design experience is an asset. Process Excellent training or certification is an asset. Leadership experience will be needed.

The Principal QA Engineer will work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Determines the direction and adequacy of designs and test results and recommends changes. Exercises judgment within broadly defined practices and policies in selecting methods and techniques to obtain desired results. Provides solutions to a wide range of difficult problems.

Requires a wide application of principles, theories and concepts in a functional engineering field. Will be responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products. Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment. Analyzes reports and returned products and recommends corrective action. Prepares documentation for inspection/testing procedures. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Has full technical responsibility for interpreting, organizing, executing, and coordinating assignments. Plans and develops engineering projects concerned with unique or controversial problems which have an important effect on major organization programs. This involves exploration of subject area, definition of scope and selection of problems for investigation and development of novel concepts and approaches.

Maintains worldwide liaison with individuals and units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field. Supervision received is essentially administrative with assignments given in terms of broad general objectives and limits. As an individual technical expert, the Principal QA Engineer conceives or is assigned plans and conducts research in problem areas of considerable scope and complexity.

processes.

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Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com