Document Control Specialist 2

Primary Function of Position

Document Control Specialist 2 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. Ensure that product and product related documents are processed through the Agile database in compliance with established procedures.  This includes simple to moderately complex Engineering Change Orders (ECOs) Manufacturing Change Orders (MCOs) Clinical Change Orders (CCO) and Beta Change Orders (BCO).  This role requires sedentary and repetitive working conditions.
 

Essential Job Duties

• Process moderately complex change orders accurately and timely using the electronic documentation system.
• Audit documentation changes for accuracy completeness and compliance with language 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 to follow up analyze and resolve open change order issues
• Raise issues applicable to the Document Control team and offer solutions.  Provide status where applicable.
• Perform additional project tasks as needed under minimal supervision

Qualifications :

Required Skills and Experience

• •  
• Experience processing changes using an electronic documentation system
• Proficient using Microsoft Office applications and Windows operating system
•   Must be able to work effectively in a fast paced team-oriented environment
• Self-starting detailed oriented and ability to focus on task at hand
• Ability to work independently with multiple departments to resolve Document Control issues
• Well-developed English written and verbal communication skills
• Good understanding of Quality System Regulations and ISO requirements

Required Education and Training

• University degree with 2 years of experience working in Document Control in a Regulatory or Quality organization at a medical device company or 4 years of equivalent work experience
• Quality System Regulations and ISO 13485 requirements 

Working Conditions

• •  
• This role requires sedentary and repetitive working conditions.

Preferred Skills and Experience

• •  
• Project Management
• Agile Lifecycle System
• Change Control Management

Additional Information :

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 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.

Mandatory Notices

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 employeeswho 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 governments 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 employeesstart 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. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time