Mayra Halvorsen Email & Phone Number

Northridge, Ca

Responsible for managing the Configuration Management/Document Control department, which includes Quality Procedures, Work Instructions, Quality Records, Practices and Tool Specifications for Configuration Management of Quality Records and Change Control. Analyze, define and develop documentation control methodologies to support company needs. Monitor and improve the integrity and maintenance of system files and workflows thought the document center. Provide documentation processes to departments including making recommendations for process improvements. Facilitate the timely release and change of documentation according to project schedules. Measure and monitor configuration management process effectiveness including the impact of process changes. Assure all documentation requirements are in compliance with specifications and standards. Communicate status of documentation changes and its configuration to engineers, project managers, managers and senior management. Define and maintain departmental record systems. Provide support as Configuration Assurance SME during external audits. Provide leadership in areas of configuration management to drive continuous process improvements.

Northridge, Ca

Responsible for managing the Configuration Management/Document Control department, which includes change process of Device Master Records and updates to the Design History Files. Supervise the day-to-day operations of the Engineering Change Order process. Facilitate the timely release and change of documentation according to project schedules. Measure and monitor configuration management process effectiveness including the impact of process changes. Ensure process work-flows are smooth and timely. Assure all documentation requirements are in compliance with specifications, standards and applicable Quality Systems Requirements. Communicate status of documentation and its configuration to engineers, project managers, managers and senior management as requested. Define and maintain Device Master Record data bases accurately to assist in document retrieving, tracking and reporting per regulations. Major contributor in developing and implementing systems for the processing of specifications, which include standard procedures, CAD, word processing and on-line documents. Provide independent review on deliverables used to develop, validate, implement, and maintain non-product-related software. Provide support as Configuration Assurance SME during external audits. Provide leadership in areas of configuration management to drive continuous process improvements.

Northridge, Ca

Process change orders in compliance with applicable procedures that support compliance with regulations and standards pertaining to medical device quality system change management. Provide direction and guidance in the change order process and work with change originators to maintain clear, concise and valid documents throughout. Collaborate with other Medtronic configuration management groups and businesses. Process parts and documents changes according to requirements and procedures to support business requirements. Drive and facilitate the change, approval and release of documentation according to project schedules, including the resolution of resource issues relative to the processing of Engineering Change Requests, Engineering Change Orders, Archive Change Orders, Document Change Requests, Data Change Notifications, Pre-Release Change Orders and Deviations. Responsible for data entry integrity when transferring changes to product data in multiple systems. Responsible for ensuring that the best practices of Part/Document Change Management are followed. Contribute to problem solving/continual improvement discussions regarding change control process, including the impact of changes and takes the initiative to recommend process improvements. Participate in department meetings and performs other tasks and related duties as assigned.

Northridge, Ca

Plan and manage the configuration of documentation and parts associated with developing and manufacturing devices throughout the product life cycle. Assist in and coordinate the creation, approval, and release of documents. Drive timely release of documentation according to project schedules through interaction with documentation authors and approvers from many levels of the organization as well as communicate status of documentation and parts configuration to engineers and project managers. Responsible for analyzing situations within defined, standard business procedures and practices for finding readily obtainable configuration management solutions to problems of moderate scope.

Chatsworth, Ca

Bachelor Of Science (B.S.), Biology, General

Associate Of Arts (A.A.), General Studies