QA Specialist, Brazil
Company: Intuitive
Location: Sunnyvale
Posted on: May 13, 2022
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Job Description:
Company Description 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 theirmost 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. Job Description Position's Objective &
Summary: The Quality Specialist for Latin America will support the
Brazilian Office maintenaning the Quality Management System (QMS)
and execute administrative activities Roles and Responsibilities:
Main activities · Maintain the Quality Management System (QMS)
assuring: - Oversee the Intuitive Sao Paulo office and ensure all
requirements by Anvisa and Intuitive are met - Keep operational
licenses updated - Harmonization between local and corporate
procedures - Adequate implementation of the procedures (ECO)-
Training control - Periodic review of the procedures - Execution of
the activities established on the QMS procedures, like CAPA,
Management Review, Purchasing, Supplier Controls, Special Labeling
and Internal & External Audits as needed - Assist Post Market
Surveillance processes such as complaint review, investigation and
reporting decisions - Assist with Field Safety Corrective Action
process such as distributor notifications and follow ups - ANVISA
report for National and Worldwide Adverse Events and Field Safety
Corrective Action - Act as a backup for the "Technical Responsible
Person" (TRP) and sign documentation as such as needed. ·
Administrative activities - Being present in the office on a daily
basis - Collecting documentation and mail and alerting the
appropriate Intuitive contact(s)- Assisting in the coordination of
onsite meetings - Assists and supports other employees, teams and
field personnel as necessary - Manage pest control and janitorial
services - Control inventory and purchase office and cafeteria
supplies Qualifications Required Knowledge, Skills, and Experience
: · Fluent in written and spoken English is required · Working
knowledge of Anvisa requirements · 2-3 years of experience in
quality processes of a medical device company · Graduated in
Biomedicine, Pharmacy, Nursing or any other life sciences
acceptable to be Technical Responsible Person · Demonstrate good
interpersonal skills and the ability to work with others in an
international team environment with effective interactions in cross
departmental teams · Ability to work autonomously, exercise daily
judgment based on above experience and knowledge · Focus on
accuracy and completeness · General Computer literacy (PC,
Microsoft Word/Excel/PowerPoint, Outlook) Additional Information
All your information will be kept confidential according to EEO
guidelines. 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. Shift : Day Travel : 10% of the time Travel
Requirements:10% of the time Shift:Day
Keywords: Intuitive, Sunnyvale , QA Specialist, Brazil, Other , Sunnyvale, California
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