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

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