Business Systems and Change Analyst

Primary Function of Position:

The Business Systems and Change Analyst is responsible for processing change orders and successfully implementing system and processes improvements in the Document Control department. The position represents Document Control department in projects and collaborates with cross-functional departments, ensuring Compliance with Intuitive Document Control Standards and Regulatory requirements.  Work closely with the senior Business and Systems Process Analysts to draft and review requirements, test scripts and execute PLM system and process updates.  This position reports directly to the Senior Manager, Document Control.

Essential Job Duties

• Execute improvement activities for the PLM system (Agile) and Document Control Processes
• Represent Document Control during requirements definition phase of projects
• Participate in planning sessions for approved projects to provide input to requirements
• Participate in multiple project teams. Work with business owners to ensure the team understands users’ business activities and that the acceptance criteria are defined.
• Participate in daily stand-ups, resolve conflict, and escalate as required
• Create test scripts related to PLM and Document Control projects. Execute User Acceptance testing.
• Work with Computer System Validation (CSV) groups in Regulatory and IT to ensure project compliance with regulatory and Intuitive CSV policies and procedures
• Identify and resolve project issues and manage project dependencies within the Document Control environment to keep the critical path on track.
• Update impacted procedures and ensure all required documentation is updated and released at the time of project implementation
• Support and Contribute to the Agile Training Forum. Provide input to slide content related to processes and PLM system questions.
• Review, assess and implement approval matrix requests. Provide support in approval matrix improvements.
• Review and assess Document Control tickets to understand issue details and requirements. Resolve the complex Document Control tickets.
• Become embedded in the process – spend a portion of time processing ECOs and responding to internal customer issues
• Support the Senior System and Business Analyst on assigned tasks and projects
• Process a daily quota of change orders to support the business
• Process complex change orders accurately and timely using the electronic documentation system, based on professional concepts and company objectives.
• 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, where analysis of situations or data requires knowledge of regulatory and change control principles.
• 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
• Raise issues applicable to the Document Control team and offer detailed solutions and alternatives with justification for actions.
• Maintain data integrity within Agile form fields and update item forms within Agile to accommodate changes within company processes and requirements
• Have in-depth Agile system and change control processes knowledge in order to troubleshoot issues as needed and know when to escalate them to IT
• Understand how Agile links to other systems within and outside Intuitive. Provide support on Agile integration-related requests.
• Update Document and Change Control procedures as needed

Required Skills and Experience

• Experience in a Regulatory/Quality organization in a medical device company
• Experience with and knowledge of both the functional and technical aspects of a PLM system, Agile preferred
• knowledge of Change Control principles for Document Control and IT systems
• Experience working on process and system improvement projects
• Working knowledge of Microsoft Office products (MS Word, MS Excel, MS Visio)
• Strong critical and analytical thinking and problem-solving skills
• Strong attention to detail.
• Planning and organizing adaptability; ability to react to project adjustments & alterations promptly and efficiently
• Experience working with 5+ person cross-functional project teams
• Ability to be both “hands on” and to work in a team-oriented, collaborative environment
• Ability to work in a high stress, ever changing environment
• Ability to communicate clearly and effectively to both business stakeholders and technical team members (e.g. IT)
• Self-starter, able to work with minimal supervision

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