Project Manager

Job Summary
We are seeking a proactive and detail-oriented Project manager to join our dynamic team. In this vital role, you will coordinate project documentation, facilitate cross-functional communication, and ensure compliance with industry standards such as ISO 13485, ISO 9001, and FDA regulations. Your technical proficiency and organizational skills will drive the smooth execution of projects within a regulated environment, supporting quality management and regulatory compliance initiatives. This position offers an exciting opportunity to contribute to innovative projects in a fast-paced setting while developing your expertise in document control, data management, and project coordination.

Duties

• Manage and maintain comprehensive document control systems, including document review, filing, and workflow management using platforms like SharePoint and document management systems.
• Oversee the creation, proofreading, and distribution of technical documents, ensuring accuracy and compliance with pharmaceutical regulatory standards.
• Coordinate project documentation processes across departments using project management software and ERP (Enterprise Resource Planning) systems to track progress and deadlines.
• Facilitate communication between engineering, quality assurance, regulatory teams, and external partners to ensure alignment on document requirements and project milestones.
• Support records management activities by organizing data entry, data management tasks, and maintaining accurate records in accordance with ISO 13485, ISO 9001, and FDA regulations.
• Assist in preparing reports, technical writing tasks, and review of documentation for compliance with legal standards in production environments.
• Contribute to continuous improvement initiatives by identifying opportunities for streamlining document workflows and enhancing document compliance practices.

Requirements

• Proven experience with document control within an engineering or manufacturing industry, preferably in a regulated environment such as pharmaceuticals or medical devices.
• Strong knowledge of ISO 13485 (medical device quality management), ISO 9001 (quality management systems), FDA regulations, and pharmaceutical regulatory compliance standards.
• Technical proficiency with Microsoft Office Suite (Word, Excel, PowerPoint), SharePoint, ERP systems, project management software, and document management tools.
• Excellent organizational skills with the ability to manage multiple priorities efficiently while maintaining attention to detail.
• Demonstrated experience in records management, data entry, proofreading, and technical writing.
• Familiarity with document workflow management processes including filing systems and document review procedures (document control).
• Effective cross-functional communication skills to collaborate seamlessly across departments and external stakeholders.
• Administrative experience supporting project teams or quality assurance functions is highly desirable.

Join us to be part of a forward-thinking organization where your expertise will help shape innovative solutions while advancing your career in a vibrant environment committed to excellence!

Pay: $21.31 - $24.09 per hour

Benefits:

• Flexible schedule

Work Location: Remote