Regulatory Post Market Surveillance Quality Engineer 3
Posted on: June 19, 2022
Company DescriptionAt 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
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
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
DescriptionPrimary Function of Position:The Post Market team at
Intuitive works at the intersection of Regulatory and Quality. The
team engages across the organization to deeply understand how our
products and processes perform, the implications of any issues, and
support the execution of robust resolutions. Functions
collaborating with the Post Market team include Post Market
Surveillance, Field Action, Data Analytics, Clinical Engineering,
Field Service, Technical Support, Customer Service, Risk
Management, Service Operations, and Failure Analysis Engineering.
The Post Market Team advocates for safety and effectiveness
improvements by assessing field product performance and QMS
processes to identify, investigate, communicate, and execute on
opportunities. The Post Market team requires a Quality Engineer
with strong, hands-on experience in problem solving, technical
savvy with complex electro-mechanical devices, and passion for the
best practices to analyze, monitor, and improve product and
process. -Roles & Responsibilities:
- Reporting to the Sr. Manager, Regulatory Post Market
Surveillance, the Regulatory, Post Market Surveillance Quality
Engineer (RPMS QE) is responsible for creating and supporting a
quality culture by driving compliance activities around the
Complaint Investigations, partnering across the organization to
manage continuous process/quality improvement programs that
strongly align with Intuitive standards and customer needs while
meeting all applicable Medical Device Regulations and
- Partner with subject matter experts on various activities
supporting Post Market improvement initiatives.
- Evolve existing processes/systems to ensure timely escalation
identification of product quality & compliance issues within a
closed loop quality management system.
- The RPMS QE will work to collect and analyze data, drive
rigorous root cause analyses and facilitate cross-functional
discussions to ensure we are seeing 'all the way around' issues for
- Participate in internal/external audits as necessary
representing the Post Market Program.QualificationsSkills,
Experience, Education, & Training:
- Minimum - Bachelor's degree (Engineering or equivalent)
combined with minimum 3 years of related experience in Quality,
Engineering, Operations, or a continuous improvement
- Strong interpersonal and communication skills:
- Passionate about making products and processes better
- Able to assist people in finding creative solutions around
- Able to deliver presentations to a broad audience
- Knowledge of Quality Systems Regulations (21 CFR 820) and ISO
- Knowledge of Process improvement tools and methodologies (Lean,
Six Sigma) is preferred. Green or Black Belt Certification in Lean
or Six Sigma is a plus.
- Experience gathering/processing internal and external
- Business Acumen - has demonstrated business knowledge and
ability to display the linkage between projects and desired
- Proven ability to drive creative problem solving related to
product and process issues.
- The ability to collaborate effectively with product and/or
process subject matter experts in a cross-functional team
environment is required.
- Technical aptitude is required to collect and analyze data for
determining an improvement strategy.
- Ability to navigate multiple projects with changing priorities.
Ability to execute to project timelines. Project Management
- Ability to travel up to 10% of the time.Additional
InformationDue 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.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. Shift : Day Travel : 10% of the timeTravel
Requirements:10% of the time Shift:Day
Keywords: Intuitive, Sunnyvale , Regulatory Post Market Surveillance Quality Engineer 3, Engineering , Sunnyvale, California
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