| • 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 |