Sr Quality Engineer
Company: ATR International
Location: Anaheim
Posted on: January 17, 2023
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Job Description:
We are seeking a Sr Quality Engineer for a very important
client. This role will be the primary quality engineering support
for a manufacturing transfer. Responsibilities may include the
following and other duties may be assigned. Collaborates with
engineering and manufacturing functions to ensure quality standards
are in place. Provides quality expertise in the areas of test
method development, process development, protocol and report
review. This may include but is not limited to equipment
qualification, controller environment qualification, test methods
and inspections. Devises and implements methods and procedures for
inspecting, testing and evaluating the precision and accuracy of
products and production equipment. Designs or specifies inspection
and testing mechanisms and equipment; conducts quality assurance
tests; and performs statistical analysis to assess the cost of and
determine the responsibility for products or materials that do not
meet required standards and specifications. Ensures that corrective
measures meet acceptable reliability standards and that
documentation is compliant with requirements. May specialize in the
areas of design, incoming material, production control, product
evaluation and reliability, inventory control and/or research and
development as they apply to product or process quality. SPECIALIST
CAREER STREAM: Typically an individual contributor with
responsibility in a professional discipline or specialty. Delivers
and/or manages projects assigned and works with other stakeholders
to achieve desired results. May act as a mentor to colleagues or
may direct the work of other lower level professionals. The
majority of time is spent delivering and overseeing the projects
from design to implementation while and adhering to policies, using
specialized knowledge and skills normally acquired through advanced
education (typically University). DIFFERENTIATING FACTORS Autonomy:
Seasoned individual contributor. Works independently under limited
supervision to determine and develop approach to solutions. Coaches
and reviews the work of lower level specialists; may manage
projects / processes. Organizational Impact: May be responsible for
entire projects or processes within job area. Contributes to the
completion of work group objectives, through building relationships
and consensus to reach agreements on assignments. Innovation and
Complexity: Problems and issues faced are difficult, and may
require understanding of multiple issues, job areas or specialties
. Makes improvements of processes, systems or products to enhance
performance of the job area. Analysis provided is indepth in nature
and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and
external customers and vendors. Exchange information of facts,
statuses, ideas and issues to achieve objective, and influence
decisionmaking. Leadership and Talent Management: May provide
guidance, coaching and training to other employees within job area.
May manage projects, requiring delegation of work and review of
others' work product . Requirement: The ideal candidate will
possess the following qualifications: Top 3 skills required:
Experience in medical device equipment and process validation
including writing/ reviewing protocols and reports; working
knowledge of medical device regulations; detail orientedtarget
years of experience: Desired 5+ Required Knowledge and Experience:
Requires advanced knowledge of job area combining breadth and
depth, typically obtained through advanced education combined with
experience. May have practical knowledge of project management.
Requires a University Degree and minimum of 4 years of relevant
experience, or advanced degree with a minimum of 2 years relevant
experience.
Keywords: ATR International, Anaheim , Sr Quality Engineer, Other , Anaheim, California
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