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 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 Description
Primary Function of Position
The Document Control Specialist is responsible for maintaining and continuously improving the Document Control Quality System in order to support the business and release of marketed products, meet regulations and established requirements. Ensures that product and product related documents are processed through the Agile database in compliance with established procedures. This includes complex Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), Clinical Change Orders (CCO), Beta Change Orders (BCO), and Deviations. This role requires sedentary and repetitive working conditions.
Essential Job Duties
- Process complex change orders accurately and timely using the electronic documentation system.
- Audit documentation changes for accuracy, completeness, and compliance with language, procedural, and regulatory requirements.
- Ensure changes are in a closed loop with all discrepancies addressed before release.
- Provide clear verbal and written communication to internal customers, including guidance to originators on correcting issues or discrepancies.
- Promptly respond to questions and issues raised by Originators and Approvers
- Collaborate with ECO Coordinators and originators (including senior and external subject matter experts) to follow up, analyze, and resolve open change order issues
- Raise issues applicable to the Document Control team and offer solutions and alternatives with justification for actions.
- Select methods and techniques for obtaining solutions and uses creative ways to solve problems
- Independently perform routine project tasks within limited scope
Qualifications
Required Skills and Experience
- University degree with 3 years’ experience working in Document Control in a Regulatory or Quality organization, or 6 years relevant work experience with a minimum of 3 years at medical device company
- Experience processing changes using an electronic documentation system
- Proficient using Microsoft Office applications, and Windows operating system
- Experience using Agile
Required Education and Training
- Product Lifecycle Management (PLM) Processes and System (preferable)
- Change Control Management
- Quality System Regulations
- ISO 13485 2016
- High school diploma
- College degree is preferable
Working Conditions
This role requires sedentary and repetitive working conditions.
Preferred Skills and Experience
- Project Management
- Agile Lifecycle System
Additional Information
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.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
