The documentation coordinator is responsible for Control, maintenance and update of quality system documents offering support to the assigned project. Control, maintain & update all the documents related to the quality system, including standard procedures, work instructions, drawings, quality manual, etc. related to assigned projects. - Control, maintain, and update all documents related to the quality system, including standard procedures, work instructions, drawings, quality manuals, etc., specifically to the assigned project to ensure project-specific documentation accuracy and relevance.Review submitted documents ensuring alignment with quality system and applicable regulatory requirements. - Review submitted documents to ensure alignment with the quality system and applicable regulatory requirements within the context of the assigned project.Support Change control management process, ensuring that any change affecting the QMS and approved appropriately. - Provide support for the Change Control Management process within the assigned project, ensuring that any change affecting the Quality Management System (QMS) is appropriately reviewed and approved in alignment with project objectives.Ensure that only the latest version of any document is available in the point of use. Discarding as needed obsolete documents accordingly with the applicable procedures. - Ensure that only the latest version of any document is available at the point of use within the assigned project, discarding obsolete documents as per applicable procedures to maintain project-specific document control.Support other assigned activities. - Support other assigned activities within the project scope to contribute to overall project success.Lead or participate in change control management meetings related to the specifically assigned project.Collaborate with the weekly metrics for ECN's & ECR's. - Collaborate in the weekly metrics for ECN's (Enterprise Change Notices) / ECR's (Enterprise Change Requests) within the context of the assigned project.3. Educational Level and Special Training Required High school minimum, bachelor's degree in engineering, or Business preferred. plus 3 to 5 years of experience in similar roll, including a minimum of three years in a medical manufacturing environment required.Considerable knowledge of quality systems for medical devicesProficient in MS Office Suite (including Word, Excel and Power Point).4. Work Experience Required 3 to 5 years of experience in similar roll, including a minimum of three years in a medical manufacturing environment required.Knowledge of 21 CFR Part 820 and ISO 13485 highly preferred.5. Qualifications and Skills Business acumen.Communication.Ethical practice.CFR 820 and applicable regulatory requirements.ISO 13485.Problem solving.Leadership and teamwork.Microsoft.English/Spanish 80%.6. Physical Requirements • Sedentary Work: Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc. Generally, involves sitting most of the time.
• Must be able to review printed material.
• Ability to operate in a fast-paced environment, sometimes requiring extended work hours.
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