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Steadfast Staffing Solutions LLC

Engineer Admin

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Job Description

Overview We are seeking a highly organized and detail-oriented Engineering Administrator to join our dynamic engineering team. This pivotal role involves managing document control processes, ensuring compliance with industry standards, and supporting cross-functional communication within the organization. The ideal candidate will possess strong technical proficiency, excellent organizational skills, and a thorough understanding of quality management systems, regulatory standards, and document workflow management. This position offers an opportunity to contribute to the integrity of engineering operations while supporting regulatory compliance in a fast-paced environment. Duties Oversee document management systems to ensure accurate filing, retrieval, and archiving of engineering documents in accordance with
ISO 13485, ISO
9001, and FDA regulations. Manage document review processes, ensuring all technical documents meet compliance standards and are properly controlled throughout their lifecycle. Facilitate document workflow management by coordinating review cycles, approvals, and version control using project management software and SharePoint. Maintain records management protocols to support regulatory/legal compliance standards in production and quality management. Assist in preparing technical documentation for audits, inspections, and regulatory submissions with meticulous proofreading and data entry. Support cross-functional communication by liaising between engineering teams, quality assurance, regulatory affairs, and external auditors. Implement best practices for document control within the engineering industry to enhance efficiency and ensure adherence to pharmaceutical regulatory compliance. Conduct regular audits of document control processes to identify areas for improvement and ensure ongoing compliance with internal policies and external regulations. Experience Proven experience in document control within the engineering or pharmaceutical industry, with a strong understanding of regulatory/legal compliance standards such as
ISO 13485, ISO
9001, and FDA regulations. Demonstrated proficiency in using document management systems, SharePoint, project management software, and Microsoft Office Suite for data management and technical writing. Familiarity with quality management principles and experience supporting audit readiness for regulatory inspections. Strong organizational skills with the ability to manage multiple projects simultaneously while maintaining accuracy. Excellent communication skills for effective cross-functional collaboration across diverse teams. Experience with records management, proofreading technical documents, and ensuring document compliance throughout various stages of production or development. Knowledge of pharmaceutical regulatory compliance requirements related to documentation and recordkeeping is highly desirable. This role is integral to maintaining the integrity of our engineering documentation processes while supporting our commitment to quality excellence. We invite qualified candidates who are eager to contribute their expertise in a collaborative environment focused on innovation and compliance.
Pay:
$19.00 - $20.00 per hour People with a criminal record are encouraged to apply
Work Location:
In person