Sr. Quality Engineer, NPD
Company: Disability Solutions
Location: Irvine
Posted on: April 20, 2024
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Job Description:
Johnson & Johnson is currently recruiting for a Senior Quality
Engineer, NPD to be based in Irvine, CA. At Johnson & Johnson, we
believe health is everything. Our strength in healthcare innovation
empowers us to build a world where complex diseases are prevented,
treated, and cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in Innovative
Medicine and MedTech, we are uniquely positioned to innovate across
the full spectrum of healthcare solutions today to deliver the
breakthroughs of tomorrow, and profoundly impact health for
humanity. Learn more at https://www.jnj.com/. The Senior Quality
Engineer - plans, coordinates and executes quality assurance
activities intended to ensure effective product quality processes
are in place and executed throughout lifecycle of product. Involved
in New Product Development (NPD) teams and other activities to
develop products, design verification tests, process validations
and quality processes to ensure compliance with the company's
Quality System policies and procedures and applicable external
requirements and standards. As needed, assists to develop
quality-engineered systems and products, and support qualification
and validation activities. Will be considered a subject matter
expert (SME) on Quality matters, relevant Quality tools and will
work on complex problems and projects. Will show leadership in
driving program/projects and innovating compliant approaches and
solutions to problems. Shares technical expertise with others and
develop other engineers. A few of the responsibilities may involve
collaborating with other members of the Design Team. Will
contribute to activities including risk management document
development, creation, and design of catheter test methods,
authoring of test protocols, and testing of products during their
development cycle. Duties include: --- Working with other
functional groups, including R&D and Operations in support of
new product development, engineering projects, quality assurance
activities, and lifecycle management. --- Utilizing Quality
Engineering tools/processes in development and implementation of
practices for the effective and efficient development, transfer,
and maintenance of products/processes throughout the product
lifecycle. --- Oversight, from a Quality NPD perspective, of the
Non-Conformance Report (NCR) process for BWI facilities located in
the U.S. --- Develop and establish effective quality control and
support associated risk management plans, AFMEA, DFMEA and PFMEA.
--- Write, review and/or approve process and product validation
protocols and reports, equipment qualifications, engineering change
orders. --- Use statistical tools to analyze data, make acceptance
decisions, and improve process capability (Six Sigma, Statistical
Process Control (SPC), Design of Experiments (DOE), etc.). Performs
statistical analysis of data generated including but not limited
to: Gauge R&R, ANOVA, Sample Size determination and
variable/attribute data analysis against predetermined acceptance
criteria. --- Ensure that development activities follow design
control requirements (Design Trace Matrix), product is tested per
applicable standards, GSPR are met per the MDR, and product is
properly transferred to manufacturing per applicable
specifications. --- Technical problem solving, failure analysis,
and root cause determination. --- Makes decisions independently on
engineering problems and methods and represents the organization in
conferences to resolve important questions and to plan and
coordinate work. --- Recommend issue resolution to management for
significant capability and compliance issues. --- Works closely
with functional leadership in planning and executing project
milestones. --- Plans, develops, coordinates, and directs one or
more large important engineering projects or several small projects
with many complex features. --- Carries out complex or novel
assignments requiring the development of new or improved techniques
or procedures. --- Assesses the feasibility and soundness of
proposed engineering evaluation tests, products or equipment, when
necessary, data are insufficient or confirmation by testing is
advisable. --- Responsible for communicating business related
issues or opportunities to next management levels. --- Responsible
for ensuring personal and Company compliance with all Federal,
State, local and Company regulations, policies, and procedures ---
Performs other duties assigned as needed
Keywords: Disability Solutions, Murrieta , Sr. Quality Engineer, NPD, Engineering , Irvine, California
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