The Medical Products Division of W. L. Gore &
Associates, Inc. is seeking a Quality Engineer to support new product
development and current manufacturing initiatives. The focus of the position is
the evaluation of fitness for use of materials, designs, processes, tests, and
products. This person will work in
conjunction with manufacturing and development teams and with other technical
associates. Activities in the scope of the position include but are not limited
to:
Gaining an understanding of product processing,
manufacturing, development as well as validation of specifications, test
methods, and fixture design for testing
Transition of new products into manufacturing and
support existing manufacturing, including the transition of these operations
from various geographic locations in the Medical Division,
Component selection, evaluation and validation from
various potential supply sources,
Use of the following systems: quality, complaints,
design control, corrective and preventive action, risk management,
non-conforming product,
Designing, executing, and analyzing experiments
based on statistical techniques,
Developing and carrying out performance tests on a
device to characterize and document its safety,
A fundamental understanding of device use, development
of visual standards, general manufacturing troubleshooting, writing procedures,
training other associates, and assisting other technical associates.
Qualifications
Critical success factors are:
A work style of hands-on involvement with all
phases of his/her projects,
Demonstrated ability to prioritize, initiate, and
drive projects to completion,
Solid knowledge of engineering fundamentals and
ability to apply this knowledge to manufacturing and product design,
Knowledge of the fundamentals of statistics,
Ability to work effectively in team situations as
well as independently,
Demonstrated excellent communication skills, both
written and oral,
Ability to network and interface effectively with a
broad range of associates spanning varied disciplines and responsibilities, and
Working understanding of GMP and ISO 9000
requirements.
Requirements/Qualifications:
A degree in Science or Engineering is required. A
minimum of 5 years of experience in an engineering capacity in the medical
device or pharmaceutical industry is desired.
Excellent written, oral and presentation skills are
required.
Desirable attributes:
An advanced technical degree,
Previous hands on experience in process, quality or
reliability engineering,
Previous hands-on experience with medical products,
Willingness to travel periodically.
Job:
Engineer/Scientist
Primary Location:
North America-United States-Arizona-Flagstaff
Travel: Yes,
5 % of the Time
Shift: Day
(1st shift)
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