• Understand, maintain, and contribute to the improvement efforts with document management processes for the BD Interventional Surgery; includes ensuring proper document templates are used, documents undergo appropriate review and approvals, documents are published with high quality standards; documents are appropriate circulated, and acknowledgements are accurately retained and well organized.
• Serve as subject matter expert for document management solution. Support efforts for implementation, training, troubleshooting, user-requests, and transition as needed.
• Prepare and maintain documents that support company and QA initiatives, such as process documents, policy documents, SOPs, templates, forms, tracking spreadsheets, meeting minutes, etc.
• Maintain quality document systems (e.g., EDMS, LMS, EPR etc.).
• Understand, maintain, and contribute to the improvement efforts with record management processes for the organization; includes ensuring record retention conventions and list are maintained and communicated, archiving room protocols are followed, and QA files are organized and maintained.
• Support QMS/QA related processes as directed. These activities are likely to include the following: Audits, CAPAs, improvement initiatives, Document Control, Record Control, Safety, QMS/Compliance Awareness and Training, Management Review, etc.
• Support customer audit/visit efforts as directed.
• Recommend quality improvements and suggestions.
• Must be able to work with different departments and individuals and help establish reasonable processes and programs to ensure compliance with all industry regulations and standards.
• Other duties and tasks that may be assigned on an as-needed basis.
• Strong interpersonal, communication and customer service skills.
• Excellent technical writing, grammar and speaking skills; ability to create and edit written material in a clear, concise, and accurate manner.
• Strong data analysis, problem analysis, and problem-solving skills.
• Ability to encourage progress, promote concepts, and maintain confidentiality.
• Strong attention to detail and appreciation for organization/order.
• Experience planning, organizing and implementing solutions that are sustainable.
• Willingness to actively collaborate, work independently, adapt to changes and changing priorities, and work under deadlines without sacrificing accuracy.
• Good time management, prioritization, judgment, and decision-making skills.
• Expert level knowledge of EDMS and LMS Systems.
• Experience with and/or quality systems / quality control compliance / ISO 13485 activities and or facilitating adult learning sessions, preferred.
• Industry specific experience preferred.
• Knowledge of tools, concepts and methodologies of QA preferred.
• Certifications that may include: Document Management Certified Professional, American Society of Quality (ASQ) Certified Quality Improvement Associate, Quality Auditor, or Six Sigma Green Belt, or similar. |
(Quality or QA or QMS) And (Document or Documentation or DMS) AND (Control or Maintenance or Development) AND ( EDMS or LMS or EPR ) And ( Record or Report or MBR ) AND( MS-Office or Excel or Word or Outlook) And( SOP)AND( CAPA ) AND(ISO 13485)AND((Lean or sigma or KAIZEN or Kanban or 5s or Green belt ) AND( Medical Devices )
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Medical Device |
Lead the implementation and optimization of Oracle TRC (Tax and Reporting Cloud) as part of a larger Oracle Fusion ERP/SCM Cloud Suite deployment.
Estimate and deliver TRC scope items, ensuring all deliverables are met on time and aligned with project goals and milestones.
Collaborate with functional and technical teams to identify gaps in the TRC configuration and functionality, and propose solutions.
Provide subject matter expertise in Oracle Tax & Reporting Cloud (TRC), including understanding of tax configurations, reporting requirements, and integration with other Oracle Cloud modules.
Work closely with business stakeholders to gather and refine TRC requirements, ensuring solutions meet the needs of the Finance, Tax, and Reporting teams.
Perform system configurations, customizations, and troubleshooting to ensure the TRC system works as expected.
Conduct unit testing, integration testing, and assist with User Acceptance Testing (UAT) to ensure all tax and reporting functionalities are functioning properly.
Lead the preparation for go-live by ensuring that all TRC-related activities, configurations, and reports are ready and aligned with the overall project plan.
Document processes, configurations, and any custom developments related to TRC to support future system maintenance and upgrades.
Train and mentor junior team members to ensure the project has the necessary support for success. |
Oracle and (TAX OR "TAX AND REPORTING CLOUD") AND FUSION
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Automotive |