CI Quality Engineer 3
Company: Intuitive
Location: Sunnyvale
Posted on: July 28, 2022
Job Description:
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 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 DescriptionPrimary Function of
Position:
The Post Market team at ISI 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 within the Post Market team include Post Market
Surveillance, Field Action, Data Analytics, Clinical Engineering,
Failure Analysis Engineering, and Continuous Improvement Quality
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 Continuous Improvement Quality
Engineering Team requires a Continuous Improvement Quality Engineer
3 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, Continuous Improvement Quality
Engineering, the Continuous Improvement Quality Engineer 3 is
responsible for creating and supporting a quality culture by
driving compliance activities around the CAPA Program, partnering
across the organization to manage continuous process/quality
improvement programs that strongly align with ISI standards and
customer needs while meeting all applicable Medical Device
Regulations and Standards. -S/he will partner with subject matter
experts on various corrective and preventive (CAPA) activities in
addition to supporting other improvement initiatives. S/he will
evolve existing processes/systems to ensure timely escalation
identification of product quality & compliance issues within a
closed loop quality management system. -
- -The CIQE 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 complete
resolution. S/he will participate in internal/external audits as
necessary representing the CAPA Program. -QualificationsSkills,
Experience, Education, & Training:
- Minimum Bachelor's degree (Engineering or equivalent) combined
with 6-8 years of related experience in Quality, Engineering,
Operations, or a continuous improvement environment. -
- Strong interpersonal and communication skills:
- Passionate about making products and processes better
- Able to assist people in finding creative solutions around
constraints.
- Able to deliver presentations to a broad audience
- Knowledge of Quality Systems Regulations (21 CFR 820) and ISO
13485 preferred.
- 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
- ASQ certification (CQE) is a plus.
- Experience gathering/processing internal and external
requirements.
- Business Acumen - has demonstrated business knowledge and
ability to display the linkage between projects and desired
business results.
- 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
experience preferred. -
- Shift: -Shift 1 - Day
- Travel: -Yes, 10 % of the TimeAdditional InformationAll your
information will be kept confidential according to EEO
guidelines.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 , CI Quality Engineer 3, Other , Sunnyvale, California
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