To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99681998_Quality_Assurance_Engineer_Supervisor.html
To see other op****tunities, please visit http://sqa.fyicenter.com
Date: 18-Jul-2008
Quality Assurance Engineer Supervisor
# Responsibilities: Provide Quality Engineering sup****t to
Manufacturing, Quality & Regulatory and Process Development teams to
ensure that products are manufactured with a high level of quality,
while being in compliance with regulations governing medical devices
manufacturing. # Serve as technical quality leader and provide
guidance in sup****t of significant or chronic process or product
investigations. # Utilize process validation methodologies, IQ/OQ/PQ
to ensure that new product / process and changes are robustly
transferred to production, partner / mentor QA Technicians to
facilitate continuous improvement efforts on production floor. #
Generate, interpret and present re****ts on quality and product
complaints to internal product improvement teams and for cor****ate
re****ting. # Manage and oversee the divisions Change Notice process;
setting priority in accordance w/ business needs, allocating resources
to complete tasks, and providing regular re****ts on progress,
problems, needs, etc, to management team. # Sup****t the implementation
of quality improvement programs. # Review and approval of procedures,
technical / validation re****ts, change notices, and non-conforming
material re****ts. # Develop and implement manufacturing process
monitoring systems to evaluate product quality. # Facilitate and
administer delivery holds, participate on internal audit team in
conducting internal quality system audits.
Requirements: # BS in Electrical/ Mechanical Engineering or science
discipline or equivalent. # Minimum of 5 years experience in medical
device industry, demonstrated understanding of, and ability to
interpret regulations and guidelines governing medical device
development, including CFRs, ISO 9000, EN 46001, and the MDD. #
Demonstrated understanding and experience in applying modern quality
assurance and control tools (statistical analysis, acceptance
sampling, DOE, gauging and gauge R&R, Statistical Process Control). #
Strong working knowledge of process development and validation
methodologies (IQ,OQ,PQ), willingness to work as a team player in a
change oriented department. # Demonstrated ability to manage/
coordinate investigations and continuous improvement projects #
Experience interacting directly with suppliers, Manufacturing, and
Manufacturing sup****t organizations preferred. # Excellent technical
writing, communication, and organizational skills required, experience
with MS Office products required, experience with a statistical
software package is a plus, ASQ Certified Quality Engineer is a plus,
Six Sigma Black Belt is a Plus. # Excellent oral and written
communication and interpersonal skills, ability to work independently
and complete multiple assignments on time, required. # Demonstrated
understanding and experience in applying modern quality engineering
and management concepts such as Six Sigma, Process capability
Analysis, Risk *****sment, PFMEA and DFMEA. # Supervisory experience
for small team of technicians and Engineers is a plus
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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