Job Overview Manage change control process and provide support to item and change order creators. Manage software projects as assigned. Job Responsibilities and Essential Duties * Analyze structure configuration for Design History Files (DHFs) and all Lifecycle Device Master Records (DMRs) for completeness within the database (Agile PLM). The content is driven by standard operating procedures. * Ensure data accuracy and completeness for all Lifecycle Engineering and Manufacturing documentation. * Conduct final configuration verification prior to product release. * Responsible for the approvals and configuration release for DHFs and all Lifecycle DMRs as multi-level complex BOM structures through the change control process, Engineering Change Orders (ECOs) within the database (Agile PLM). * Accountable for ensuring documentation follow GDP and SOP's as defined by Atrium's policies, procedures, and Quality Management System (QMS) to ensure that FDA and ISO standards are consistently met. * Provide training and guidance to employees for creating, maintaining, and obsoleting complex multi-level BOM configurations and engineering documentation within the database (Agile PLM) for DHFs and all Lifecycle DMRs. * Work with project leads to drive software and digital projects to completion. Includes but not limited to software products, mobile applications, and web applications. * Develop, document, and maintain project plans. * Determine resource needs and work with functional managers and FP&A on resource planning. * Organize project team meetings, set meeting agendas, issue minutes, and follow up on action items. Minimum Requirements * Associates Degree or related experience, with direct experience in engineering documentation and BOM structures. * Minimum 2-5 years' experience in Document Control in a QMS regulated industry. * Strong knowledge of electronic documentation management system (Agile PLM preferred). * Advanced computer skills in MS Office applications (Excel, Word) are required. Required Knowledge, Skills and Abilities * Demonstrated ability to communicate effectively, with clear and concise oral and written communication. * Ability to interpret and analyze diverse change orders and assess compliance to standards utilizing independent judgment consistently and appropriately. * Customer driven work ethic with a sense of urgency/priority in responding to business needs. * Advanced computer skills in MS Office applications (Excel, Word) are required. * Strong knowledge of electronic documentation management system (Agile PLM preferred). Supervision/Management Of Others: * N/A Internal and External Contacts/Relationships * N/A Environmental/Safety/Physical Work Conditions * Ensures environmental consciousness and safe practices are exhibited in decisions. Compensation: $25/hr to $30/hr depending on experience
LI-Hybrid
#LI-YA2
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Getinge
Jun 10, 2025