Acclarent, Inc., a member of Johnson & Johnson's
Family of Companies, is recruiting for a Senior
Manager, Quality Engineering, located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in
Menlo Park, CA that was established in June of
2004. The company is dedicated to the development
of innovative devices providing new technologies
to further meet the needs of ENT patients.
Acclarent's initial focus is on achieving the
goals of sinus surgery with novel, endoscopic,
catheter-based tools - Balloon Sinuplasty™
devices. Through the Balloon Sinuplasty™
technology and our RelievaŽ product portfolio we
offer ENT patients another option to conventional
endoscopic surgical technologies. FDA clearances
for these devices were completed in 2005 and the
products were commercially launched in the US that same year.
Through our core technologies and commitment to
innovation, Acclarent will continue to advance
novel devices in all areas of ENT.
The Senior Manager, Quality Engineering designs
and implements process improvements for the
Quality Engineering function, including design
controls, risk management, statistical process
control, and test method validation. They ensure
that quality engineering procedures are compliant
with internal, customer, and regulatory
requirements, leading CAPA activities to address
nonconformances. They monitor internal and
external standards changes related to quality
engineering requirements, develop compliance
strategies and lead cross-functional teams to
implement changes to the quality system.
The Senior Manager, Quality Engineering provides
design control and risk management guidance to
new product development teams. They oversee the
execution of product post market surveillance
plans. The individual develops training materials
and conducts training for R&D, Quality
Engineering, and Manufacturing on best-in-class
quality engineering practices for design control,
risk management, root cause analysis and the
application of statistical methods. They apply
knowledge of engineering principles and practices
to implement continuous improvement projects.
A minimum of a Bachelor's degree in an
Engineering, Scientific or related discipline is
required. A minimum of 7 years of professional
experience in a medical device manufacturing and
product development environment is required. A
working knowledge of the FDA Quality System
Regulation, ISO 13485, and the EU Medical Device
Directive is required. The incumbent must be
skilled in the implementation of ISO 14971,
including risk evaluation techniques, such as
FMEA or fault tree analysis. It is required that
this candidate be familiar with test methods and
standards for the design, verification, and
validation of medical device products, including
sterilization, biocompatibility, reliability,
electrical safety, and packaging validation.
Demonstrated experience in process improvement is
required. Six Sigma certification is a plus.
Demonstrated project management and people
leadership skills required. The individual must
have experience leading CAPA activities. It is
highly desired that this individual be skilled in
the application of statistical methods, including
ANOVA, statistical process control, sampling
plans, gauge R&R, design of experiments, and
reliability demonstration. Excellent verbal
(including presentation) and written
communication skills are required. CQE certification is a plus.
This position may require minimal (0 -10 %)
travel and is located in Menlo Park, CA.
BE VITAL in your career, Be seen for the talent
you bring to your work. Explore opportunities
within the Johnson & Johnson Family of Companies.
Karen Stafford
Team Member, Sourcing
Acro Staffing, providing services for
Johnson & Johnson Global Recruiting
kstaffo1_at_its.jnj.com
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Received on 2013-04-11 14:54:19