Description:
JOB TITLE: DOCUMENT CHANGE CONTROL LEAD
Primary Function of Position:
This is a "hands on" position with global responsibilities. The Document Change Control Lead is responsible for assisting Document Change Control Management in leading the team's maintenance and continuous improvement of the Document Control Quality System in order to support the release of marketed products and meet regulations and established requirements. This includes project leadership of improvement activities for the document management system (Agile) and training on the system for both Document Control personnel and other ISI functions that participate in the change control process. Having solid knowledge on Engineering validation and qualification concept and process, the lead should work to ensure that product and product related documents are processed through the Agile (or appropriate) database in compliance with established procedures creating and implementing, Engineering Change Orders (ECOs), BETA CHANGE ORDER (BCO), CLINICAL CHANGE ORDER (CCO), Manufacturing Change Orders (MCOs), Deviations and Engineering Change Requests (ECRs).
In addition to processing changes, the Lead serves as the subject matter expert (SME) for all Change Control processes and for change control compliance issues. The position is responsible for ensuring that Change Analysts in all locations, both domestically and internationally, follow Change Control established procedures and process changes in a manner to support established goals and metrics. The Lead functions as the global escalation point for Change Control process issues and related compliance concerns. 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
• Maintain data integrity within the form fields and update item forms within Agile to accommodate changes within company processes and company growth
• Have in-depth Agile system and change control processes knowledge in order to "trouble shoot" issues as needed and know when to escalate them to IT
• Have a clear understanding as to how Agile is used in other departments and functional areas within Intuitive, as well as at other Intuitive sites and supplier locations
• Document appropriate changes to system functionality and processes
• Maintain/update Document Control procedures as needed
• Process changes approximately 20 hours per week
• Assist project lead for system changes and other Document Control projects. May be required to complete system UAT testing
• Along with Process Analyst Implement improvements to department procedures , conduct New Hire training, and train Change Analysts on new procedures
• Ensure that Service Now tickets are addressed in a timely manner
• Implement productivity and quality goals set by Sr. Manager of department
• Regularly review and monitor monthly metrics to ensure that productivity goals are met.
• Implement and monitor quality and compliance requirements and quality check/audit procedures to ensure that quality goals are being met.
• Assess the impact AGILE documents have on QS Training and work with QS Training to resolve any Agile training issues as needed
• Work with Change Analysts and business partners to resolve all questions/issues
• Ensure record retention requirements
• Provide support, as needed, by assisting in the coordination and prioritization of change order backlog and customer request fulfillment
• Lead Change Analyst weekly meeting and attend meetings to represent Document Control. Management as needed.
• Participate in audits as required
Skills, Experience, Education, & Training:
Minimum position requirements:
• Education
o Four year college degree, preferred
o In lieu of 4 year degree, 2 years of post-high school education or completion of an Associate Degree
• Experience
o Minimum of 8+ total years' experience working in Document Control in a Regulatory/Quality organization in a medical device company with a minimum of 2 years as a Lead or Sr. Change Analyst is required Experience with a Learning Management System and its links to Document Control processes
o Preferred experience in developing training aids and delivering technical training to a cross functional audience
o Solid understanding of Quality System Regulations ( CFR 820, FDA GMP) ISO requirements (13485),
o Working knowledge of Design History and Design Control requirements
o Preferred Demonstrated practical experience in AGILE system or other Change Management System , processes and documentation
• Skills
o Excellent customer service skills
o Must be able to work effectively in a fast paced, team-oriented environment
o Ability to work independently without supervision
o Demonstrated ability with database applications especially Microsoft Office Suite, including Microsoft Project
o Ability to analyze metrics and Change Control Relevant data
o Demonstrated ability to build cross functional consensus for changes and to achieve project goals
o Self-starting, detailed oriented, and ability to focus on task at hand
o Ability to work independently with personnel from multiple departments in order to resolve Document Control issues
o Excellent English written and verbal communication skills
• Training
(Preferred)
o Product Lifecycle Management (PLM) Processes and System
o Change Control Management
o People Management
o Quality System Regulations
o ISO 13485 2016
