Document Control Coordinator / Administrator - Canada
- To administer a product lifecycle management (PLM) system: AGILE.
- The AGILE system will maintain the configuration of the products.
- The AGILE system has an integration with the company’s ERP system – SAP and all part changes will be controlled through this system.
- The Document Control Coordinator / Administrator will coordinate activities related to site document control within AGILE including review and processing of site major and minor change orders to support new product introductions and sustaining engineering activities.
DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS:
- Reviews site change requests and change orders for compliance to procedures, formats and content.
- Processes change requests and change orders at each phase, ensuring correct approvals are obtained and all comments are addressed.
- Conducts employee training on change order process and procedures, including AGILE training and system access.
- Develops and publishes metrics supporting the document control system, and summarizes in reports as needed.
- Develops and implements document and AGILE system improvements in the form of continuous improvement projects and compliance initiatives.
- Participates in validation of the AGILE system for use by the site.
- Participates in quality system improvement projects and assists in compliance gap remediation as needed.
- Support and actively participate in internal audit program
- Other duties as assigned
Experience: 3 – 5 years related work experience, working in a regulated environment (medical device experience preferred)
- Extensive knowledge of ISO 13485, FDA CFR 820, CMDR standards and regulations.
- Demonstrated ability to work effectively and positively with all levels of an organization.
- Capable of working both independently and in a team setting; team oriented and committed to continuous improvement.
- Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
- Strong organization skills required.