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Job Details

Regulatory and Quality

Company name
Intuitive Surgical, Inc.

Location
Durham, NC, United States

Employment Type
Full-Time

Posted on
Jun 08, 2021

Valid Through
Sep 21, 2021

Apply for this job






Profile

Regulatory and Quality','US-NC-Durham-US-NC-Durham','','','','Full-time','','false','Quality Assurance Associate','212380','!*!At Intuitive, 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. Our mission is our guiding force; our culture is the DNA that makes us unique.  

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges. 

We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse 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 strive to 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 help to 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 support.

Major Responsibilities:

Product Release

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

Reviews and approves records from sterilization sub-contractors to assure sterility of single-use products

Ensures that any non-conformances or deviations are properly approved and documented in the DHR

Works collaboratively with internal customers to resolve DHR issues in a timely manner

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 company objectives.

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 follow-up.

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 requirements. 

Effective Communicator: Excellent verbal and written communication skills.  Skilled at making use of visual aides to convey complex concepts to diverse audiences.

','!*!Skill Requirements:

Minimum 2 years of operational experience in a Product Quality or certified (e.g. FDA, ISO, Mil-Spec, etc.) manufacturing environment

Minimum 2 years of education or 2 years of experience in the quality space.

Exceptional analytical, problem-solving, and root-cause analysis skills

Excellent verbal and written communication

General familiarity with spreadsheet, word processing, and email software

Understanding of, or aptitude to understand, Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820

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.  

','Quality Assurance Associate

Company info

Intuitive Surgical, Inc.
Website : https://www.intuitive.com

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