Quality Assurance Associate
Company: Advantage xPO
Posted on: January 16, 2022
At Intuitive, we are united behind our mission: we believe that
minimally invasive care is life-enhancing care. Through ingenuity
and intelligent technology, we expand the potential of physicians
to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we
strive to foster an inclusive and diverse team, committed to making
a difference. For more than 25 years, we have worked with hospitals
and care teams around the world to help solve some of healthcare's
hardest challenges and advance what is possible. - Intuitive has
been built by the efforts of great people from diverse backgrounds.
We believe great ideas can come from anywhere-we strive to foster
an inclusive culture built around diversity of thought and mutual
respect. We lead with inclusion and empower our team members to do
their best work as their most authentic selves.
Passionate people who want to make a difference drive our
culture-our team members are grounded in integrity, have a strong
capacity to learn, the energy to get things done, and bring
diverse, real world experiences to help us think in new ways. We
actively invest in our team members to support their long-term
growth so they can continue to advance our mission and achieve
their highest potential.
Join a team committed to taking big leaps forward for a global
community of healthcare professionals and their patients. Together,
let's advance the world of minimally invasive care.
Primary function of position - The Quality Assurance (QA) Associate
is responsible for reviewing device history records (DHRs) for
accuracy and completeness, certifying compliance to product
specification and traceability requirements and ensuring that any
deviations from the manufacturing process were properly recorded
and authorized by members of the appropriate departments.
The QA Associate receives guidance on workload prioritization from
the team lead but is ultimately responsible for organizing and
executing their projects and daily standard workload in a manner
which meets the schedules of the operational teams whom they
--- Product Release
o Reviews DHRs for da Vinci systems, instruments, and accessories
for compliance to product specifications and company traceability
requirements, creating certification documents and authorizing
release of product for distribution to customers and New Product
Introduction (NPI) launches
o Reviews and approves records from sterilization sub-contractors
to assure sterility of single-use products
o Ensures that any non-conformances or deviations are properly
approved and documented in the DHR
o Works collaboratively with internal customers to resolve DHR
issues in a timely manner
o Reports on workload status regularly within the team and
identifies issues which pose a potential risk to team goals
--- Performs inventory transactions and ensures that released
products are transacted in a timely manner to maintain inventory
accuracy for department inventory locations
--- Participates in department process improvement projects or
other activities as directed by management
Critical Competencies for Success
--- Team-Oriented: Approaches their work selflessly and without
ego, making an honest effort to manage their own assigned workload,
communicating openly and in a timely manner when deliverables are
at risk, and actively seeking opportunities to ask "How can I
help?" - Freely shares information and makes it a priority to
mentor their peers when the opportunity presents itself.
--- Quick Study & Continuous Learner: Demonstrates aptitude for
learning new processes quickly, actively seeks deeper understanding
of processes and functions critical to their role. - Strives to
understand the bigger picture and how their role supports key
--- Perceptive & Detail Oriented: Skilled at sensing variations
from the norm and thoroughly investigating whether compliance to
company process has been maintained. - Demonstrates ability to
execute competently and consistently to fundamental job skills
while advancing knowledge in more complex disciplines.
--- Initiative & Follow-through: Seeks opportunities to improve
departmental process and expand personal contributions. - Can be
relied upon to complete commitments without excessive
--- Good Judgment: Strong ability to draw correlations to prior
experience and identify precedent in ambiguous circumstances. -
Demonstrated track record of making good decisions.
--- Ethical & Independent: Demonstrates recognition of the
criticality of the job function and strives to conduct themselves
in a manner which does not invite doubt about their ability to
consistently execute process without direct supervision. - Does not
cut corners or bow to external pressure to compromise on
--- Effective Communicator: Excellent verbal and written
communication skills. - Skilled at making use of visual aides to
convey complex concepts to diverse audiences.
Qualifications - External
--- Minimum 2+ years of operational experience in a Product Quality
or certified (e.g. FDA, ISO, Mil-Spec, etc.) manufacturing
--- Exceptional analytical, problem-solving, and root-cause
--- Excellent verbal and written communication
--- General familiarity with spreadsheet, word processing, and
--- Understanding of, or aptitude to understand, Medical Device QMS
and regulatory requirements including, but not limited to, ISO13485
and U.S. FDA 21CFR820
Due to the nature of our business and the role, please note that
Intuitive and/or your customer(s) may require that you show current
proof of vaccination against certain diseases including COVID-19. -
Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide
equal employment opportunities to all qualified applicants and
employees, and prohibit discrimination and harassment of any type,
without regard to race, sex, pregnancy, sexual orientation, gender
identity, national origin, color, age, religion, protected veteran
or disability status, genetic information or any other status
protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest
and conviction records in accordance with fair chance laws.
About Advantage xPO
Advantage xPO is committed to providing equal employment
opportunity for all persons regardless of race, color, religion
(including religious dress and grooming practices), sex, sexual
orientation, gender, gender identity, gender expression, age,
marital status, national origin, ancestry, citizenship status,
pregnancy, medical condition, genetic information, mental and
physical disability, political affiliation, union membership,
status as a parent, military or veteran status or other non-merit
based factors. We will provide reasonable accommodations throughout
the application, interviewing and employment process. If you
require a reasonable accommodation, contact us. Advantage xPO is an
E-Verify employer. This policy is applicable to all phases of the
employment relationship, including hiring, transfers, promotions,
training, terminations, working conditions, compensation, benefits,
and other terms and conditions of employment.
All employees are directed to familiarize themselves with this
policy and to act in accordance with it. All decisions with respect
to employment matters and other phases of employer-temporary
employee relationships will be in keeping with this policy and in
accordance with all applicable laws and regulations.
Keywords: Advantage xPO, Sunnyvale , Quality Assurance Associate, Other , Sunnyvale, California
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