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 3 is responsible for assisting the Document Control lead and manager in 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, Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), Deviations and Engineering Change Requests (ECRs). This role requires sedentary and repetitive working conditions.
Roles & Responsibilities:
- Process documentation changes in Agile: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes accurately and in a timely manner while ensuring that they meet the department goals and objectives
- Audit changes for accuracy and completion. Review changes to ensure that language used in the change is adequate and in compliance. Ensure that changes are in a closed loop and all discrepancies (if any) are addressed and closed before the change is released
- Provide clear and accurate communication to internal customers. Clearly communicate both verbally and in writing, with Originators when discrepancies are found. Give precise guidance to originators for the proper process to follow when to correct issues/discrepancies.
- Provide Agile and change procedure training support as needed to co-workers within and outside Document Control
- Promptly respond to questions and issues raised by Originators and Approvers
- Work with ECO Coordinator to select changes for CCB meetings based on production impact
- Represent Document Control at CCB meetings
- Work with ECO Coordinator and Originators in following-up, analyzing and helping to resolve open ECO/MCO issues
- Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals
- Familiarity with Design History requirements and documents
- Experience with and, clear understanding of the Quality System Regulations and ISO 13485 requirements
- Lead/participate in projects/assignments that support continuous improvement efforts and department/company goals
- Provide change control training (processes and system) to users
- Maintain change control training materials up to date
- Create and maintain change control metrics and reports
Qualifications
Skills, Experience, Education, & Training:
Education
- Minimum High school diploma
- College degree is preferable
Experience
- 5+ years’ experience working in Document Control in a Regulatory or Quality organization with a minimum of 3 years at medical device company
- Experience processing changes using an electronic documentation system
- Proficient using Word and Excel applications, and Windows operating system
- Experience using Agile
Skills
- Must be able to work effectively in a fast paced, team oriented environment
- Ability to work independently with minimal supervision
- Demonstrated ability with database applications. Proficient using Word and Excel application, and Windows operating system
- Demonstrated cross-functional teamwork skills
- 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
Training (Preferable)
- Product Lifecycle Management (PLM) Processes and System
- Change Control Management
- Quality System Regulations
- ISO 13485 2016
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 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.
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 salary ranges are listed.
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